Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Tumor
- Sponsor
- UroSee Corporation
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assessment of the utility and performance of the cystoscope by the physician
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
- •Ambulatory and able to undergo routine cystoscopy in the lithotomy position.
Exclusion Criteria
- •History of prior bladder/urethral surgery other than TURBT; or
- •History of interstitial cystitis; or
- •Presence of urinary tract infection (UTI); or
- •Gross hematuria; or
- •History of pelvic radiation therapy; or
- •Procidentia; or
- •Unable to read, understand, and/or provide a ranking of pain level during the procedure; or
- •Unable or unwilling to provide consent to participation in the study.
Outcomes
Primary Outcomes
Assessment of the utility and performance of the cystoscope by the physician
Time Frame: during the procedure
Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device
Secondary Outcomes
- Patient tolerance of the procedure(during and within 5 days after the procedure)