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.
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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||Start Date: November 5, 2016||N/A||Observational|
Primary Outcome 1 - Measure: Assessment of the utility and performance of the cystoscope by the physician
Primary Outcome 1 - Time Frame: during the procedure
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.
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
8. Unable or unwilling to provide consent to participation in the study.
Minimum Age: 18 Years
Maximum Age: 90 Years
Healthy Volunteers: Accepts Healthy Volunteers
Name: Bela Denes, MD
Role: Study Director
Affiliation: UroSee Corporation
Name: Thomas Lawson, PhD
Phone: 510 206 1794
|Las Vegas Urology
Las Vegas, Nevada 89128
Vijay Goli, MD