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.
Study Type
OBSERVATIONAL
Enrollment
30
Diagnostic cystoscopic procedure of the urethra and bladder
Las Vegas Urology
Las Vegas, Nevada, United States
RECRUITINGAssessment of the utility and performance of the cystoscope by the physician
Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device
Time frame: during the procedure
Patient tolerance of the procedure
Assess level of discomfort or adverse event associated with the procedure by the subject using the Likert Scale
Time frame: during and within 5 days after the procedure
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