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Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope

NCT03040466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-10-01

Study results available
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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.

Conditions

  • Kidney Calculi
  • Ureter Calculi

Interventions

DEVICE

reusable fiberoptic ureteroscope

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

DEVICE

disposable digital ureteroscope

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

Sponsors & Collaborators

Principal Investigators

  • Thomas Chi, MD · Urology, University of California San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-09-30
Completion
2016-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040466 on ClinicalTrials.gov