Bladder Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Bladder Cancer

Estimated Enrollment:

140

Study ID:

NCT06422312

Recruitment Status:

Not yet recruiting

Sponsor:

Guangzhou Red Pine Medical Instrument Co., Ltd.

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There are 2 Locations for this study

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Pennsylvania State University
Hershey Pennsylvania, 17033, United States More Info
Suzanne L Boltz, B.S.
Contact
717-531-0003
[email protected]
Amogh Pande, M.S.
Contact
717-531-5930
[email protected]
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Brett Johnson, MD
Contact
214-645-8765
[email protected]
Sonobia Garrett, BS
Contact
214-645-8482
[email protected]
Brett Johnson, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

140

Study ID:

NCT06422312

Recruitment Status:

Not yet recruiting

Sponsor:


Guangzhou Red Pine Medical Instrument Co., Ltd.

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