Clinical trial NCT06422312: A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.
Official title: Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bladder Cancer
Bladder Stone
Bladder Outlet Obstruction
Renal Stone
Renal Disease
Keywords: cystoscopy
Lead sponsor: Guangzhou Red Pine Medical Instrument Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Texas Southwestern Medical Center
name: University of Washington
name: Penn State University
First posted: 2024-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative Procedure Time
timeFrame: 30 minutes
Secondary outcomes:
measure: User experience and product performance during cystoscopic procedures
timeFrame: within 24 hours
measure: Participant comfort during the procedure
timeFrame: 30 minutes
measure: RedPine Cystoscope Conversion Rate
timeFrame: 30 minutes
measure: Device Failure Rate
timeFrame: 30 minutes
Other outcomes:
measure: Safety Endpoints
timeFrame: 4 to 10 days
Locations:
city: Hersey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: UT Southwestern Medical Center
name: Yair Lotan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.
citation: Poulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November).
citation: 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.
citation: 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.
citation: Steinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview
citation: 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.