Spots Global Cancer Trial Database for Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures

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Trial Identification

Brief Title: Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures

Official Title: Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder

Study ID: NCT03331705

Conditions

Bladder Tumor

Interventions

Uro-C (Use of new cystoscope)

Study Description

Brief Summary: This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.

Detailed Description: A new cystoscope has been designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. The cystoscope, named the Uro-C, is light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that contains video electronics, is wireless capable, and has a liquid crystal display (LCD) monitor. Cystoscopy with the new system is performed in a standard manner to cystoscopy with currently available endoscopes, so risks are no different than when currently available endoscopes are used. This is a prospective, multi-center, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of the cystoscope for direct visualization of the urethra and bladder.