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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Tumor
• Intervention / Treatment: Device: Uro-C (Use of new cystoscope)

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Thomas Lawson, PhD; Phone Number: 510 206 1794; Email: thom@urosee.com
• Study Contact Backup: Name: Bela Denes, MD; Phone Number: 949 378 0268; Email: bdenes@urosee.com

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Recruiting
      • Las Vegas Urology
      • Contact: Vijay Goli, MD; Phone Number: 702-233-0727
      • Contact: Marian Bertola, RN; Phone Number: 702 385 4343

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Females requiring a diagnostic cystoscopic procedure

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UroSee Corporation
• Investigators: Study Director: Bela Denes, MD, UroSee Corporation

Study record dates

Study Major Dates

• Study Start: November 5, 2016
• Primary Completion (Anticipated): July 5, 2018
• Study Completion (Anticipated): September 5, 2018

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided