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
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2016
CompletedFirst Submitted
Initial submission to the registry
October 26, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2018
CompletedNovember 6, 2017
October 1, 2017
1.7 years
October 26, 2017
November 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Patient tolerance of the procedure
during and within 5 days after the procedure
Study Arms (1)
Use of new cystoscope
Patients in which the cystoscope is used.
Interventions
Diagnostic cystoscopic procedure of the urethra and bladder
Eligibility Criteria
Females requiring a diagnostic cystoscopic procedure
You may qualify if:
- Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
- Ambulatory and able to undergo routine cystoscopy in the lithotomy position.
You may not qualify if:
- History of prior bladder/urethral surgery other than TURBT; or
- History of interstitial cystitis; or
- Presence of urinary tract infection (UTI); or
- Gross hematuria; or
- History of pelvic radiation therapy; or
- Procidentia; or
- Unable to read, understand, and/or provide a ranking of pain level during the procedure; or
- Unable or unwilling to provide consent to participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Las Vegas Urology
Las Vegas, Nevada, 89128, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bela Denes, MD
UroSee Corporation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2017
First Posted
November 6, 2017
Study Start
November 5, 2016
Primary Completion
July 5, 2018
Study Completion
September 5, 2018
Last Updated
November 6, 2017
Record last verified: 2017-10