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

NCT06422312 | Withdrawn FDA Device

• 1 other identifier: USA001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Bladder Cancer; Bladder Stone; Bladder Outlet Obstruction; Renal Stone; Renal Disease

Keywords

cystoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• User experience and product performance during cystoscopic procedures

  within 24 hours

• Participant comfort during the procedure

  30 minutes

• RedPine Cystoscope Conversion Rate

  30 minutes

• Device Failure Rate

  30 minutes

Other Outcomes (1)

• Safety Endpoints

  4 to 10 days

Study Arms (2)

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.

Device: Cystoscopy with standard of care flexible reusable scope

Intervention

EXPERIMENTAL

Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.

Device: Cystoscopy with RedPine flexible disposable cystoscope

Interventions

Cystoscopy with RedPine flexible disposable cystoscope DEVICE

Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.

Intervention

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

Control

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Red Pine Medical Instrument Co., Ltd.: lead
• University of Texas Southwestern Medical Center: collaborator
• University of Washington: collaborator
• Penn State University: collaborator

Study Sites (3)

Pennsylvania State University

Hersey, Pennsylvania, 17033, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (7)

• 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.

  PMID: 19076146 BACKGROUND

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

  PMID: 8081563 BACKGROUND

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

  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.

  PMID: 19966704 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.

  PMID: 21887113 BACKGROUND

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

  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.

  PMID: 27988848 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urinary Bladder Calculi; Urinary Bladder Neck Obstruction; Nephrolithiasis; Kidney Diseases

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Calculi; Urolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urethral Obstruction; Urethral Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Yair Lotan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Vice Chair of Clinical Affairs Chief of Urologic Oncology

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)