CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
reusable fiberoptic ureteroscope +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03040466
NCT03040466N/ACompleted

Randomized Controlled Trial Comparing Disposable to Reusable Flexible Ureteroscope for Treatment of Upper Urinary Tract Stone

University of California, San Francisco·interventional·Posted Feb 2, 2017·Updated Oct 1, 2020

In Brief

A clinical study evaluating reusable fiberoptic ureteroscope and disposable digital ureteroscope for Kidney Calculi and Ureter Calculi. Completed, enrolled 180 participants across 1 site.

Detailed Summary

Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital. Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2, 2017
Enrollment StartAug 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.4 years ago

Interventions

reusable fiberoptic ureteroscopedevice

We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.

disposable digital ureteroscopedevice

We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.