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
|Condition or disease||Intervention/treatment|
|Bladder Tumor||Device: Uro-C (Use of new cystoscope)|
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|
|Estimated Enrollment :||30 participants|
|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|
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
- 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
- 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
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
|Contact: Thomas Lawson, PhD||510 206 firstname.lastname@example.org|
|Contact: Bela Denes, MD||949 378 email@example.com|
|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|
|Study Director:||Bela Denes, MD||UroSee Corporation|