Trial Outcomes & Findings for Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope (NCT NCT03040466)
NCT ID: NCT03040466
Last Updated: 2020-10-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes
Results posted on
2020-10-01
Participant Flow
Participant milestones
| Measure |
Reusable Fiberoptic Ureteroscope
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
|
Disposable Digital Ureteroscope
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
115
|
|
Overall Study
COMPLETED
|
65
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope
Baseline characteristics by cohort
| Measure |
Reusable Fiberoptic Ureteroscope
n=65 Participants
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
|
Disposable Digital Ureteroscope
n=115 Participants
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 15.1 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 14.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutesOutcome measures
| Measure |
Reusable Fiberoptic Ureteroscope
n=65 Participants
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
|
Disposable Digital Ureteroscope
n=115 Participants
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
|
|---|---|---|
|
Overall Procedure Time
|
64.5 minutes
Standard Deviation 37.0
|
54.1 minutes
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: three month after surgeryPopulation: Postoperative imaging was requested of all patients, but the total study group did not follow up with kidney, ureter, and bladder radiograph or ultrasound surveillance imaging. Participants with post operative imaging included here.
this will be determined by either CT, US, or KUB
Outcome measures
| Measure |
Reusable Fiberoptic Ureteroscope
n=38 Participants
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
|
Disposable Digital Ureteroscope
n=40 Participants
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
|
|---|---|---|
|
Number of Participants That Are Stone Free
|
17 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: from during the surgery to three months after the surgeryOutcome measures
| Measure |
Reusable Fiberoptic Ureteroscope
n=65 Participants
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
|
Disposable Digital Ureteroscope
n=115 Participants
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
|
|---|---|---|
|
Number of Participants With Complications
|
9 Participants
|
9 Participants
|
Adverse Events
Reusable Fiberoptic Ureteroscope
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Disposable Digital Ureteroscope
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reusable Fiberoptic Ureteroscope
n=65 participants at risk
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
|
Disposable Digital Ureteroscope
n=115 participants at risk
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
|
|---|---|---|
|
Surgical and medical procedures
Presence of postoperative complications
|
13.8%
9/65
|
7.8%
9/115
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place