A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.

Bladder Cancer Clinical Trial

Official title:

Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422312
• Other study ID #: USA001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Guangzhou Red Pine Medical Instrument Co., Ltd.
• Contact: Greg Lips
• Phone: 800-570-4962
• Email: Gregl[@]uroessentials.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Outlet Obstruction
• Renal Disease
• Renal Stone
• Urinary Bladder Neck Obstruction

Intervention

Device:
• Cystoscopy with RedPine flexible disposable cystoscope
Use of a flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Pennsylvania State University	Hershey	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Guangzhou Red Pine Medical Instrument Co., Ltd.	Penn State University, University of Texas Southwestern Medical Center, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View Citation

O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5. — View 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. — View Citation

Poulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November).

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. — View Citation

Steinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.; All urologic adverse events, both device and procedure related, during the cystoscopy procedure through 7 (+/- 3) days post-procedure.; All reported device and/or procedural related adverse events through 7 (+/- 3) days post- procedure; All Serious Adverse Events (SAEs) through 7 (+/- 3) days post-procedure	4 to 10 days
Primary	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.	30 minutes
Secondary	User experience and product performance during cystoscopic procedures	Physician satisfaction, rated on a five-point scale. i) Ease of insertion ii) Ability to visualize anatomical landmarks and/or urothelium changes iii) Perception of image quality iv) Maneuverability in the bladder v) Scope articulation with tools in the working channel vi) Visualization while tools are in the working channel	within 24 hours
Secondary	Participant comfort during the procedure	Participants will be interviewed using a questionnaire.	30 minutes
Secondary	RedPine Cystoscope Conversion Rate	Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope.	30 minutes
Secondary	Device Failure Rate	Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope.	30 minutes
Secondary	Device Malfunction Rate	Device malfunction including any device-related issue or observation whether it leads to an SAE, termination of the procedure or conversion to a reusable cystoscope.	30 minutes