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

November 2, 2017 updated by: UroSee Corporation

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: during the procedure
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
Time Frame: 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
during and within 5 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UroSee Corporation

Investigators

  • Study Director: Bela Denes, MD, UroSee Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 16-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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