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A change in marketing strategy resulted in a decision to not complete the trial.
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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
| University of Washington | OTHER |
| Penn State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice. |
|
| Intervention | Experimental | Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystoscopy with RedPine flexible disposable cystoscope | Device | Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints | 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:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yair Lotan, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania State University | Hersey | Pennsylvania | 17033 | United States | ||
| UT Southwestern Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19076146 | Background | Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8. | |
| 8081563 | Background | O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5. |
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| Cystoscopy with standard of care flexible reusable scope | Device | Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents |
|
| 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 | 30 minutes |
| RedPine Cystoscope Conversion Rate | Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope. | 30 minutes |
| Device Failure Rate | Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope. | 30 minutes |
| 4 to 10 days |
| Dallas |
| Texas |
| 75390 |
| United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Background | Poulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November). |
| 19966704 | Background | Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626. |
| 21887113 | Background | Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19. |
| Background | Steinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview |
| 27988848 | Background | Doizi S, Kamphuis G, Giusti G, Palmero JL, Patterson JM, Proietti S, Straub M, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris): a European prospective multicenter study. World J Urol. 2017 Aug;35(8):1269-1275. doi: 10.1007/s00345-016-1986-0. Epub 2016 Dec 17. |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D001744 | Urinary Bladder Calculi |
| D001748 | Urinary Bladder Neck Obstruction |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052878 | Urolithiasis |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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