Bladder Tumor Clinical Trial
Official title:
Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder
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.
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