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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331705
Recruitment Status : Unknown
Verified October 2017 by UroSee Corporation.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Bladder Tumor 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder
Study Start Date : November 5, 2016
Estimated Primary Completion Date : July 5, 2018
Estimated Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Females requiring a diagnostic cystoscopic procedure
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331705


Contacts
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Contact: Thomas Lawson, PhD 510 206 1794 thom@urosee.com
Contact: Bela Denes, MD 949 378 0268 bdenes@urosee.com

Locations
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United States, Nevada
Las Vegas Urology Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Vijay Goli, MD    702-233-0727      
Contact: Marian Bertola, RN    702 385 4343      
Sponsors and Collaborators
UroSee Corporation
Investigators
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Study Director: Bela Denes, MD UroSee Corporation
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Responsible Party: UroSee Corporation
ClinicalTrials.gov Identifier: NCT03331705    
Other Study ID Numbers: 16-001
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases