Bladder Cancer, Bladder Outlet Obstruction, Bladder Stone, Renal Disease, Renal Stone
Conditions
Keywords
cystoscopy
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.
Interventions
DEVICECystoscopy with RedPine flexible disposable cystoscope
Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.
DEVICECystoscopy with standard of care flexible reusable scope
Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents
Sponsors
University of Texas Southwestern Medical Center
University of Washington
Penn State University
Guangzhou Red Pine Medical Instrument Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged at least 18 years old 2. Patient undergoing routine flexible cystoscopy 3. No active urinary tract infection 4. Subject is willing and able to sign informed consent and HIPAA authorization.
Exclusion criteria
1. Known unpassable urethral stricture 2. Febrile patient with active urinary tract infection (UTI) 3. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis) 4. Subject with severe coagulopathy 5. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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/No |
| Participant 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 pain |
| RedPine 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoints | 4 to 10 days | Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure. 1\) All urologic adverse events, both device and procedure related, during the cystoscopy procedure through 7 (+/- 3) days post-procedure. The subject will be asked if they have had: 1. any signs or symptoms of a UTI 2. any untoward effects post-procedure, including by not limited to 1. gross hematuria last longer than 3 days post-procedure 2. pain with urination lasting longer than 3 days post-procedure 3. cloudy urine noted greater than one day post-procedure 4. fever/chills or a diagnosis of UTI or other illness within the time since the cystoscopic procedure. 2\) All reported device and/or procedural related adverse events through 7 (+/- 3) days post- procedure 3) All Serious Adverse Events (SAEs) through 7 (+/- 3) days post-procedure |
Countries
United States
Outcome results
None listed