Trial Outcomes & Findings for A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology (NCT NCT04505956)
NCT ID: NCT04505956
Last Updated: 2024-10-09
Results Overview
Total operative times between Moses holmium laser lithotripsy and non-Moses holmium laser lithotripsy in the ureteroscopic treatment of renal stones using a dusting technique
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
171 participants
Primary outcome timeframe
Beginning to end of procedure time, assessed up to 2 hours
Results posted on
2024-10-09
Participant Flow
Participant milestones
| Measure |
Moses Laser Lithotripsy
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Holmium laser lithotripsy with Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
|
Standard Laser Lithotripsy
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Holmium laser lithotripsy without Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
|
Overall Study
COMPLETED
|
74
|
79
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology
Baseline characteristics by cohort
| Measure |
Standard Laser Lithotripsy
n=79 Participants
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Holmium laser lithotripsy without Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
|
Moses Laser Lithotripsy
n=74 Participants
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Holmium laser lithotripsy with Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
61 years
n=107 Participants
|
61 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body mass index (BMI, kg/m2)
|
31.14 kg/m2
n=99 Participants
|
30.21 kg/m2
n=107 Participants
|
30.45 kg/m2
n=206 Participants
|
|
Laterality of stones
Right
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Laterality of stones
Left
|
44 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Maximum axial stone size
|
9.7 millimeters
n=99 Participants
|
10.0 millimeters
n=107 Participants
|
10.0 millimeters
n=206 Participants
|
PRIMARY outcome
Timeframe: Beginning to end of procedure time, assessed up to 2 hoursTotal operative times between Moses holmium laser lithotripsy and non-Moses holmium laser lithotripsy in the ureteroscopic treatment of renal stones using a dusting technique
Outcome measures
| Measure |
Standard Laser Lithotripsy
n=79 Participants
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Holmium laser lithotripsy without Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
|
Moses Laser Lithotripsy
n=74 Participants
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Holmium laser lithotripsy with Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
|
|---|---|---|
|
Operative Time
|
36 minutes
Interval 30.0 to 50.0
|
37 minutes
Interval 31.0 to 51.0
|
SECONDARY outcome
Timeframe: First 20 seconds of laser lithotripsyPopulation: Video could not be taken for all trial patients. Videos were obtained and stored when feasible.
Stone movement during laser lithotripsy will be recorded on video and graded on a Likert scale by blinded reviewers. Video could not be taken for all trial patients. Videos were obtained and stored when feasible.
Outcome measures
| Measure |
Standard Laser Lithotripsy
n=61 Participants
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Holmium laser lithotripsy without Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
|
Moses Laser Lithotripsy
n=57 Participants
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Holmium laser lithotripsy with Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
|
|---|---|---|
|
Stone Retropulsion
No retropulsion
|
18 videos (1 video per participant)
|
27 videos (1 video per participant)
|
|
Stone Retropulsion
Some retropulsion
|
32 videos (1 video per participant)
|
21 videos (1 video per participant)
|
|
Stone Retropulsion
Significant retropulsion
|
11 videos (1 video per participant)
|
9 videos (1 video per participant)
|
Adverse Events
Standard Laser Lithotripsy
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Moses Laser Lithotripsy
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Laser Lithotripsy
n=79 participants at risk
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Holmium laser lithotripsy without Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
|
Moses Laser Lithotripsy
n=74 participants at risk
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Holmium laser lithotripsy with Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
|
|---|---|---|
|
Infections and infestations
Severe urinary tract infection
|
6.3%
5/79 • 30 days postoperatively
|
2.7%
2/74 • 30 days postoperatively
|
|
Surgical and medical procedures
Repeat surgical intervention for pain or stone fragments
|
1.3%
1/79 • 30 days postoperatively
|
2.7%
2/74 • 30 days postoperatively
|
|
Renal and urinary disorders
Readmission for pain
|
0.00%
0/79 • 30 days postoperatively
|
1.4%
1/74 • 30 days postoperatively
|
|
Renal and urinary disorders
Urinary retention requiring foley catheter placement
|
1.3%
1/79 • 30 days postoperatively
|
0.00%
0/74 • 30 days postoperatively
|
Other adverse events
| Measure |
Standard Laser Lithotripsy
n=79 participants at risk
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Holmium laser lithotripsy without Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
|
Moses Laser Lithotripsy
n=74 participants at risk
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Holmium laser lithotripsy with Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
|
|---|---|---|
|
Renal and urinary disorders
Present to ED with renal colic
|
1.3%
1/79 • 30 days postoperatively
|
2.7%
2/74 • 30 days postoperatively
|
|
Renal and urinary disorders
Urinary retention
|
1.3%
1/79 • 30 days postoperatively
|
1.4%
1/74 • 30 days postoperatively
|
|
Renal and urinary disorders
Presented to ED with pain, fevers and treated for UTI
|
1.3%
1/79 • 30 days postoperatively
|
0.00%
0/74 • 30 days postoperatively
|
Additional Information
Nicole Miller, M.D.
Vanderbilt University Medical Center - Department of Urology
Phone: (615) 322-3807
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place