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Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.
This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.
This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Pennsylvania State University
Hersey, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Start Date
October 1, 2024
Primary Completion Date
January 1, 2025
Completion Date
July 1, 2025
Last Updated
April 4, 2025
Cystoscopy with RedPine flexible disposable cystoscope
DEVICE
Cystoscopy with standard of care flexible reusable scope
DEVICE
Lead Sponsor
Guangzhou Red Pine Medical Instrument Co., Ltd.
Collaborators
NCT04235764
NCT03375307
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00026884