Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope

Completed · Not applicable

Conditions studied: Kidney Calculi, Ureter Calculi

In brief

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.

Key facts

Study ID

NCT03040466

Run by

University of California, San Francisco

People needed

180

Starts

2014-08-01

Expected to finish

2016-09-01

Last updated by the study team

2020-10-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 years of age at their first clinical visit.
• Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging
• Patients being able and willing to provide consent.

You may not qualify if…

• Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
• Pregnancy.
• Staged ureteroscopic procedure.
• Antegrade flexible ureteroscopy.
• Dual procedures (ureteroscopy concurrently performed with other operations).

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.