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

Launched by GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD. · May 15, 2024

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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.