Status:
UNKNOWN
Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures
Lead Sponsor:
UroSee Corporation
Conditions:
Bladder Tumor
Eligibility:
FEMALE
18-90 years
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 assess...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 5 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03331705
Start Date
November 5 2016
End Date
September 5 2018
Last Update
November 6 2017
Active Locations (1)
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1
Las Vegas Urology
Las Vegas, Nevada, United States, 89128