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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder

Conditions
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Bladder Tumor

Intervention / Treatment
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* Device: Uro-C (Use of new cystoscope)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Use of new cystoscope<br>Patients in which the cystoscope is used. | Device: Uro-C (Use of new cystoscope)<br>* Diagnostic cystoscopic procedure of the urethra and bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment 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 | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerance of the procedure | Assess level of discomfort or adverse event associated with the procedure by the subject using the Likert Scale | during and within 5 days after the procedure |