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BRIEF TITLE: Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder

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


  • Org Study ID: 16-001
  • Secondary ID:
  • NCT ID: NCT03331705
  • NCT Alias:
  • Sponsor: UroSee Corporation - Industry
  • Source: UroSee Corporation

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.

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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: November 5, 2016 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Assessment of the utility and performance of the cystoscope by the physician

Primary Outcome 1 - Time Frame: during the procedure

Condition:

  • Bladder Tumor

Eligibility

Criteria:
Inclusion Criteria:

1. Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for
diagnostic purposes; and

2. Ambulatory and able to undergo routine cystoscopy in the lithotomy position.

Exclusion Criteria:

1. History of prior bladder/urethral surgery other than TURBT; or

2. History of interstitial cystitis; or

3. Presence of urinary tract infection (UTI); or

4. Gross hematuria; or

5. History of pelvic radiation therapy; or

6. Procidentia; or

7. Unable to read, understand, and/or provide a ranking of pain level during the
procedure; or

8. Unable or unwilling to provide consent to participation in the study.
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Gender: Female

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: Accepts Healthy Volunteers

Official Information

Name: Bela Denes, MD

Role: Study Director

Affiliation: UroSee Corporation

Overall Contact

Name: Thomas Lawson, PhD

Phone: 510 206 1794

Email: thom@urosee.com

Location

Facility Status Contact
Las Vegas Urology
Las Vegas, Nevada 89128
United States
Recruiting Vijay Goli, MD
702-233-0727