NCT03331705

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: UroSee Corporation · Industry
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bladder Tumor

Interventions

Type	Name	Description
DEVICE	Uro-C (Use of new cystoscope)	Diagnostic cystoscopic procedure of the urethra and bladder

Timeline

• Start date: 2016-11-05
• Primary completion: 2018-07-05
• Completion: 2018-09-05
• First posted: 2017-11-06
• Last updated: 2017-11-06

Locations

1 site across 1 country: United States