LithoVue Single Use Disposable Ureteroscope

Kidney Stone Clinical Trial

Official title: Prospective Trial of a Reusable Digital Flexible Ureteroscope vs a Single-Use Flexible Ureteroscope in the Treatment of Urolithiasis: An EDGE Consortium Clinical Trial

Status Active, not recruiting

Clinical Trial Summary

Most flexible ureteroscopes that are used to treat kidney stones have been reusable. Recently, advances in technology have resulted in single-use (disposable) ureteroscopes to become available. The investigators are interested in determining if the performance of the two types of scopes are equivalent. This will help guide institutions in the future to purchase the best scopes for their patients.

Clinical Trial Description

Ureteroscopy is commonly used in the treatment of kidney stones. Flexible ureteroscopes are costly to purchase and repair. Issues with flexible ureteroscopes include loss of deflection and visual performance (fiberoptic pixels) with use and the high repair costs. Reprocessing and sterilization of reusable ureteroscopes also requires staff who are specially trained and dedicated in this area. Inadequate sterilization could also lead to transmissible infections between patients. A single-use flexible digital ureteroscope has recently become commercially available (LithoVue, Boston Scientific, Marlborough, MA). Pre-clinical testing show the accessibility to the ureter and all areas of the kidney to be equivalent to current flexible ureteroscopes. However, clinical data comparing this single-use ureteroscope to a current state of the art reusable ureteroscope is lacking. Establishing at least equivalence in performance between the new single use ureteroscope and a reusable digital ureteroscope will help surgeons and operating room managers/administrators help determine how to most efficiently equip their operating rooms with endoscopic equipment. ;

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

• NCT number: NCT03419091
• Study type: Interventional
• Source: University of British Columbia
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Completion date: December 30, 2023