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

• Conditions: Bladder Tumor

• Registration Number: NCT03331705
• Lead Sponsor: UroSee Corporation

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.

Study Timeline

• Study Start: 2016-11-05
• Status Verified: 2017-10
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-02
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06
• Primary Completion: 2018-07-05
• Study Completion: 2018-09-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
2. Ambulatory and able to undergo routine cystoscopy in the lithotomy position.

Exclusion Criteria

1. History of prior bladder/urethral surgery other than TURBT; or
2. History of interstitial cystitis; or
3. Presence of urinary tract infection (UTI); or
4. Gross hematuria; or
5. History of pelvic radiation therapy; or
6. Procidentia; or
7. Unable to read, understand, and/or provide a ranking of pain level during the procedure; or
8. Unable or unwilling to provide consent to participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the utility and performance of the cystoscope by the physician	during the procedure	Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device

Secondary Outcome Measures

Name	Time	Method
Patient tolerance of the procedure	during and within 5 days after the procedure	Assess level of discomfort or adverse event associated with the procedure by the subject using the Likert Scale

Trial Locations

Locations (1)

Las Vegas Urology; 🇺🇸 Las Vegas, Nevada, United States