Trial Outcomes & Findings for Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones (NCT NCT02028559)
NCT ID: NCT02028559
Last Updated: 2026-06-01
Results Overview
Percentage of study participants for which stone motion was observed on the real-time ultrasound images.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
172 participants
Primary outcome timeframe
At the time of the procedure. To be evaluated with each therapy pulse over an approximately 1-hour study. Confirmed with post-procedure review of the study video.
Results posted on
2026-06-01
Participant Flow
Participants were recruited based on physician referral and identification of potential qualifying individuals through review of the clinic patient list. Participants were recruited between December of 2013 and July of 2024. The first participant was enrolled on December 17, 2013 and the last participant was enrolled on July 23, 2024.
172 subjects are considered enrolled in this study for one of the groups defined below. 249 subjects were consented for the study. 77 subjects screen failed after consent but before undergoing any ultrasonic propulsion procedure. Since these subjects did not qualify for the study and were not assigned to an arm/group, they are not considered enrolled or included in the data provided below. The start of the study is defined as receiving at least one ultrasonic propulsion therapy pulse.
Participant milestones
| Measure |
First in Human (FIH)
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Residual Fragment (Control Group)
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
2
|
18
|
16
|
13
|
54
|
54
|
|
Overall Study
Per Protocol Population
|
15
|
2
|
18
|
16
|
13
|
49
|
53
|
|
Overall Study
COMPLETED
|
15
|
2
|
18
|
10
|
8
|
44
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
6
|
5
|
10
|
15
|
Reasons for withdrawal
| Measure |
First in Human (FIH)
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Residual Fragment (Control Group)
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Underwent standard-of-care surgery
|
0
|
0
|
0
|
5
|
5
|
7
|
11
|
Baseline Characteristics
Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
Baseline characteristics by cohort
| Measure |
First in Human (FIH)
n=15 Participants
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts .
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
n=2 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
n=18 Participants
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
n=16 Participants
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
n=13 Participants
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
n=54 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Residual Fragment (Control Group)
n=54 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Ultrasonic Propulsion · Female
|
4 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=48 Participants
|
5 Participants
n=100 Participants
|
4 Participants
n=201 Participants
|
17 Participants
n=1000 Participants
|
21 Participants
n=58 Participants
|
57 Participants
n=61 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 11 • n=24 Participants
|
70 years
STANDARD_DEVIATION 0 • n=24 Participants
|
58 years
STANDARD_DEVIATION 15 • n=48 Participants
|
51 years
STANDARD_DEVIATION 19 • n=100 Participants
|
40 years
STANDARD_DEVIATION 16 • n=201 Participants
|
60 years
STANDARD_DEVIATION 16 • n=1000 Participants
|
60 years
STANDARD_DEVIATION 12 • n=58 Participants
|
58 years
STANDARD_DEVIATION 15 • n=61 Participants
|
|
Sex: Female, Male
Ultrasonic Propulsion · Male
|
11 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
12 Participants
n=48 Participants
|
11 Participants
n=100 Participants
|
9 Participants
n=201 Participants
|
37 Participants
n=1000 Participants
|
33 Participants
n=58 Participants
|
115 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
2 Participants
n=100 Participants
|
2 Participants
n=201 Participants
|
5 Participants
n=1000 Participants
|
5 Participants
n=58 Participants
|
14 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
18 Participants
n=48 Participants
|
14 Participants
n=100 Participants
|
11 Participants
n=201 Participants
|
49 Participants
n=1000 Participants
|
49 Participants
n=58 Participants
|
158 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=201 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
n=58 Participants
|
2 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
1 Participants
n=100 Participants
|
2 Participants
n=201 Participants
|
0 Participants
n=1000 Participants
|
6 Participants
n=58 Participants
|
13 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
1 Participants
n=1000 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=100 Participants
|
1 Participants
n=201 Participants
|
2 Participants
n=1000 Participants
|
2 Participants
n=58 Participants
|
6 Participants
n=61 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
17 Participants
n=48 Participants
|
14 Participants
n=100 Participants
|
9 Participants
n=201 Participants
|
48 Participants
n=1000 Participants
|
43 Participants
n=58 Participants
|
144 Participants
n=61 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
2 Participants
n=1000 Participants
|
1 Participants
n=58 Participants
|
3 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
1 Participants
n=1000 Participants
|
2 Participants
n=58 Participants
|
3 Participants
n=61 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=24 Participants
|
2 participants
n=24 Participants
|
18 participants
n=48 Participants
|
16 participants
n=100 Participants
|
13 participants
n=201 Participants
|
54 participants
n=1000 Participants
|
54 participants
n=58 Participants
|
172 participants
n=61 Participants
|
|
Body-Mass Index (BMI)
|
29.4 kg/m^2
STANDARD_DEVIATION 2.9 • n=24 Participants
|
29 kg/m^2
STANDARD_DEVIATION 0 • n=24 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 5.0 • n=48 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 4.2 • n=100 Participants
|
24.7 kg/m^2
STANDARD_DEVIATION 4.5 • n=201 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 5.2 • n=1000 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 6.6 • n=58 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 5.5 • n=61 Participants
|
|
Renal Side
Left
|
6 Participants
n=24 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
1 Participants
n=24 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
9 Participants
n=48 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
9 Participants
n=100 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
8 Participants
n=201 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
41 Participants
n=1000 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
32 Participants
n=58 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
106 Participants
n=61 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
|
Renal Side
Right
|
10 Participants
n=24 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
1 Participants
n=24 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
10 Participants
n=48 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
7 Participants
n=100 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
5 Participants
n=201 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
13 Participants
n=1000 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
22 Participants
n=58 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
68 Participants
n=61 Participants • Analysis Population includes both kidneys if more than one side is targeted in a single session. This applies specifically to the FIH population and the URS population, where both kidneys were targeted in a single subject (which counts as two kidney units).
|
|
Target (Stone) Location
Lower pole
|
24 Number of Targets (Stone)
n=24 Participants
|
4 Number of Targets (Stone)
n=24 Participants
|
20 Number of Targets (Stone)
n=48 Participants
|
0 Number of Targets (Stone)
n=100 Participants
|
0 Number of Targets (Stone)
n=201 Participants
|
58 Number of Targets (Stone)
n=1000 Participants
|
54 Number of Targets (Stone)
n=58 Participants
|
160 Number of Targets (Stone)
n=61 Participants
|
|
Target (Stone) Location
Mid pole
|
11 Number of Targets (Stone)
n=24 Participants
|
1 Number of Targets (Stone)
n=24 Participants
|
28 Number of Targets (Stone)
n=48 Participants
|
0 Number of Targets (Stone)
n=100 Participants
|
0 Number of Targets (Stone)
n=201 Participants
|
18 Number of Targets (Stone)
n=1000 Participants
|
20 Number of Targets (Stone)
n=58 Participants
|
78 Number of Targets (Stone)
n=61 Participants
|
|
Target (Stone) Location
Upper pole
|
4 Number of Targets (Stone)
n=24 Participants
|
0 Number of Targets (Stone)
n=24 Participants
|
14 Number of Targets (Stone)
n=48 Participants
|
0 Number of Targets (Stone)
n=100 Participants
|
0 Number of Targets (Stone)
n=201 Participants
|
1 Number of Targets (Stone)
n=1000 Participants
|
7 Number of Targets (Stone)
n=58 Participants
|
26 Number of Targets (Stone)
n=61 Participants
|
|
Target (Stone) Location
Renal Pelvis / UPJ
|
4 Number of Targets (Stone)
n=24 Participants
|
0 Number of Targets (Stone)
n=24 Participants
|
0 Number of Targets (Stone)
n=48 Participants
|
3 Number of Targets (Stone)
n=100 Participants
|
0 Number of Targets (Stone)
n=201 Participants
|
0 Number of Targets (Stone)
n=1000 Participants
|
0 Number of Targets (Stone)
n=58 Participants
|
7 Number of Targets (Stone)
n=61 Participants
|
|
Target (Stone) Location
Distal Ureter / UVJ
|
0 Number of Targets (Stone)
n=24 Participants
|
0 Number of Targets (Stone)
n=24 Participants
|
0 Number of Targets (Stone)
n=48 Participants
|
13 Number of Targets (Stone)
n=100 Participants
|
13 Number of Targets (Stone)
n=201 Participants
|
0 Number of Targets (Stone)
n=1000 Participants
|
0 Number of Targets (Stone)
n=58 Participants
|
26 Number of Targets (Stone)
n=61 Participants
|
PRIMARY outcome
Timeframe: At the time of the procedure. To be evaluated with each therapy pulse over an approximately 1-hour study. Confirmed with post-procedure review of the study video.Population: All subjects who were exposed to at least one ultrasonic propulsion burst.
Percentage of study participants for which stone motion was observed on the real-time ultrasound images.
Outcome measures
| Measure |
First in Human (FIH)
n=15 Participants
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
n=2 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
n=18 Participants
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
n=16 Participants
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
n=13 Participants
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
n=54 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Residual Fragment (Control Group)
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
|---|---|---|---|---|---|---|---|
|
Measurement of Stone Motion Caused by Ultrasound
|
14 Participants
|
1 Participants
|
15 Participants
|
11 Participants
|
8 Participants
|
41 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measurement occurs over 3 weeks (weekly phone call or email encounter with the subject) plus review of the subject's medical chart up to the point the subject is exited from the study.Population: Outcome is appropriate for participants with a de novo small stone, obstructing stone, or residual fragment population. Outcome is not appropriate for participants undergoing the procedure concurrently with URS. There is no means to differentiate fragments passed as a result of their standard-of-care lithotripsy procedure versus fragments that passed as a result of the ultrasonic propulsion - since both are done concurrently.
The percentage of participants reporting visual observation of stone passage or confirmed with follow-up imaging. For the residual fragment RCT population specifically, the percentage of participants reporting visual observation of stone passage during the 3-week follow-up period after the procedure or randomization (Control group).
Outcome measures
| Measure |
First in Human (FIH)
n=9 Participants
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
n=2 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
n=16 Participants
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
n=13 Participants
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
n=52 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Residual Fragment (Control Group)
n=53 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
|---|---|---|---|---|---|---|---|
|
Measurement of Stone Passage
|
4 Participants
|
0 Participants
|
—
|
11 Participants
|
7 Participants
|
35 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Measurement up to 5 years post-procedure. This includes a phone call or email exchange semi-annually for up to 3-years and a medical record review (including imaging) semi-annually for up to 5-years.Population: Outcome was only pre-specified for the Residual Fragment population, which was a randomized trial that included a Treatment group (who underwent the ultrasonic propulsion procedure) and a concurrent Control group (that did not receive the ultrasonic propulsion procedure). Study follow up was limited to 90 days for all other populations.
The percentage of participants experiencing stone relapse defined as: an unscheduled, symptomatic visit for stones on the study side, surgery for stones on the study side, or stone growth of a residual fragment measured by clinical imaging exams. This measurement is specific to the residual fragment population and associated randomized control trial. Only a single relapse event is counted per participant, though a participant could experience more than one event.
Outcome measures
| Measure |
First in Human (FIH)
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
n=52 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Residual Fragment (Control Group)
n=53 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
|---|---|---|---|---|---|---|---|
|
Measurement of Relapse
|
—
|
—
|
—
|
—
|
—
|
8 Participants
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of the procedure. To be evaluated over an approximately 1 hour study.Population: All subjects who were exposed to at least one ultrasonic propulsion burst. Analysis population does not include the "Concurrent with URS" group as the participants are not awake for the procedure.
Pre-Procedure: The participant will be asked directly what discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), they are experiencing and to point to where the discomfort/pain is located. This is the participant's recorded baseline measure. During Procedure: The participant will be asked directly if they are experiencing any new or different discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), and to point to where the discomfort/pain is located. Any new or different discomfort above baseline will be assumed related to the device or procedure; there is no minimum threshold for reporting. Post Procedure: The participant will be asked directly what discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), they are experiencing and to point to where the discomfort/pain is located. Any new or different discomfort above baseline will be assumed related to the device or procedure; there is no minimum threshold for reporting.
Outcome measures
| Measure |
First in Human (FIH)
n=13 Participants
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
n=2 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
n=16 Participants
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
n=13 Participants
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
n=54 Participants
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Residual Fragment (Control Group)
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Discomfort Related to the Device or Procedure
|
2 Participants
|
0 Participants
|
—
|
2 Participants
|
3 Participants
|
15 Participants
|
—
|
Adverse Events
Residual Fragment (Control Group)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 3 deaths
First in Human (FIH)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
De Novo Small Stone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Concurrent With URS
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Obstructing Stone - Pushing Only
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Obstructing Stone - Dislodging + Pushing
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Residual Fragment (Treatment Group)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Residual Fragment (Control Group)
n=54 participants at risk
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
First in Human (FIH)
n=15 participants at risk
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
n=2 participants at risk
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
n=18 participants at risk
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
n=16 participants at risk
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
n=13 participants at risk
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
n=54 participants at risk
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/54 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
5.6%
1/18 • Number of events 1 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
6.2%
1/16 • Number of events 1 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/54 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
Other adverse events
| Measure |
Residual Fragment (Control Group)
n=54 participants at risk
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
|
First in Human (FIH)
n=15 participants at risk
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Propulse 1: Move kidney stones with Propulse 1 device.
|
De Novo Small Stone
n=2 participants at risk
Segment of the trial focused specifically on subjects with small (\< 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Concurrent With URS
n=18 participants at risk
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their URS laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Pushing Only
n=16 participants at risk
Segment of the trial focused specifically on subjects reporting to clinic or the emergency deparment with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity. A second obstructing stone population (n = 13) also receives higher amplitude (up to 7 MPa) shorter duration dislodging pulses.
Propulse 1: Move kidney stones with Propulse 1 device.
|
Obstructing Stone - Dislodging + Pushing
n=13 participants at risk
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only group based on the selection of participants with stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
|
Residual Fragment (Treatment Group)
n=54 participants at risk
Segment of the trial focused specifically on subjects with small (\< 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Propulse 1: Move kidney stones with Propulse 1 device.
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Effects
|
0.00%
0/54 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
6.7%
1/15 • Number of events 1 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
11.1%
2/18 • Number of events 2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
5.6%
3/54 • Number of events 3 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Nervous system disorders
Pain
|
31.5%
17/54 • Number of events 24 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
13.3%
2/15 • Number of events 2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
—
0/0 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
6.2%
1/16 • Number of events 1 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
38.9%
21/54 • Number of events 28 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Renal and urinary disorders
Hematuria
|
5.6%
3/54 • Number of events 3 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
—
0/0 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
6.2%
1/16 • Number of events 1 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
46.2%
6/13 • Number of events 6 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
7.4%
4/54 • Number of events 4 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Renal and urinary disorders
Change in Urinary Frequency
|
5.6%
3/54 • Number of events 4 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
—
0/0 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
11.1%
6/54 • Number of events 8 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Renal and urinary disorders
Change in Urinary Urgency
|
0.00%
0/54 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
—
0/0 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
9.3%
5/54 • Number of events 5 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Renal and urinary disorders
Dysuria
|
3.7%
2/54 • Number of events 2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
—
0/0 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
7.4%
4/54 • Number of events 4 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
3/54 • Number of events 3 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
—
0/0 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
5.6%
3/54 • Number of events 4 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Gastrointestinal disorders
Emesis
|
3.7%
2/54 • Number of events 2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
—
0/0 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/54 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/18 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
5.6%
3/54 • Number of events 3 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
2/54 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/18 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
9.3%
5/54 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
|
Renal and urinary disorders
Change in other Voiding Habits (i.e. slow flow)
|
1.9%
1/54 • Number of events 1 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/15 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/18 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/16 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
0.00%
0/13 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
3.7%
2/54 • Number of events 2 • AE data were collected through contact with participants once per week for 3 weeks post-procedure or randomization (Control group). Medical charts were also reviewed out to 90 days post-procedure or randomization for any additional AEs not captured during the 3-week follow-up. The residual fragment population was additionally followed up to 5 years post-procedure or randomization. AEs were not collected, but participant deaths were recorded.
Per the definition of adverse events, those events temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research, are listed. Other than skin effects, AEs for the URS population are not listed as they are confounded by the URS procedure. AEs for the Control group were based on review of the residual fragment RCT data by a clinician blinded to the participant's randomization status.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place