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

Status unconfirmed

Conditions studied: Bladder Tumor

In brief

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.

Key facts

Study ID

NCT03331705

Run by

UroSee Corporation

People needed

30

Starts

2016-11-05

Expected to finish

2018-09-05

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Las Vegas Urology — Las Vegas, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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