Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures
Study Details
Study Description
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 assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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-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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Use of new cystoscope Patients in which the cystoscope is used. |
Device: Uro-C (Use of new cystoscope)
Diagnostic cystoscopic procedure of the urethra and bladder
|
Outcome Measures
Primary Outcome Measures
- Assessment of the utility and performance of the cystoscope by the physician [during the procedure]
Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device
Secondary Outcome Measures
- Patient tolerance of the procedure [during and within 5 days after the procedure]
Assess level of discomfort or adverse event associated with the procedure by the subject using the Likert Scale
Eligibility Criteria
Criteria
Inclusion Criteria:
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Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
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Ambulatory and able to undergo routine cystoscopy in the lithotomy position.
Exclusion Criteria:
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History of prior bladder/urethral surgery other than TURBT; or
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History of interstitial cystitis; or
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Presence of urinary tract infection (UTI); or
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Gross hematuria; or
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History of pelvic radiation therapy; or
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Procidentia; or
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Unable to read, understand, and/or provide a ranking of pain level during the procedure; or
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Unable or unwilling to provide consent to participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Las Vegas Urology | Las Vegas | Nevada | United States | 89128 |
Sponsors and Collaborators
- UroSee Corporation
Investigators
- Study Director: Bela Denes, MD, UroSee Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-001