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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.
Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents
Pennsylvania State University
Hersey, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Cumulative Procedure Time
To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the site's Standard of Care reusable flexible cystoscope as measured by: * Scope preparation for procedure * Actual procedure time (insertion of cystoscope to complete bladder examination) and * Time to dispose of or prepare for reprocessing of cystoscopy equipment.
Time frame: 30 minutes
User experience and product performance during cystoscopic procedures
Physician satisfaction, rated on a five-point scale. Scale Name Very Difficult Very Easy Outcome Ease of insertion 1 5 5 = Better Ability to visualize anatomical landmarks and/or urothelium changes 1 5 5 = Better Perception of image quality 1 5 5 = Better Maneuverability in the bladder 1 5 5 = Better Overall Acceptability Yes/No
Time frame: within 24 hours
Participant comfort during the procedure
Participants will be interviewed using a questionnaire. Pain Intensity Please respond to the question by marking one box. How would you rate your pain on average? 0 1 2 3 4 5 6 7 8 9 10 No pain Worst imaginable pain
Time frame: 30 minutes
RedPine Cystoscope Conversion Rate
Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope.
Time frame: 30 minutes
Device Failure Rate
Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope.
Time frame: 30 minutes
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