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

Bladder Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331705
• Other study ID #: 16-001
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2017
• Last updated: November 2, 2017
• Start date: November 5, 2016
• Est. completion date: September 5, 2018

Study information

• Verified date: October 2017
• Source: UroSee Corporation
• Contact: Thomas Lawson, PhD
• Phone: 510 206 1794
• Email: thom[@]urosee.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 5, 2018
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Tumor
• Urinary Bladder Neoplasms

Intervention

Device:
• Uro-C (Use of new cystoscope)
Diagnostic cystoscopic procedure of the urethra and bladder

Locations

Country	Name	City	State
United States	Las Vegas Urology	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
UroSee Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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