A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.
- Conditions
- Bladder CancerBladder StoneRenal DiseaseBladder Outlet ObstructionRenal Stone
- Registration Number
- NCT06422312
- Lead Sponsor
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 140
- Male or female, aged at least 18 years old
- Patient undergoing routine flexible cystoscopy
- No active urinary tract infection
- Subject is willing and able to sign informed consent and HIPAA authorization.
- Known unpassable urethral stricture
- Febrile patient with active urinary tract infection (UTI)
- Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
- Subject with severe coagulopathy
- Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cumulative Procedure Time 30 minutes 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.
- Secondary Outcome Measures
Name Time Method User experience and product performance during cystoscopic procedures within 24 hours 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/NoParticipant comfort during the procedure 30 minutes 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 painRedPine Cystoscope Conversion Rate 30 minutes Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope.
Device Failure Rate 30 minutes Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope.
Trial Locations
- Locations (3)
Pennsylvania State University
🇺🇸Hersey, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Pennsylvania State University🇺🇸Hersey, Pennsylvania, United States