WithdrawnNot Applicable

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

Stopped: A change in marketing strategy resulted in a decision to not complete the trial.

United States0Started 2024-10

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexALL

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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.

What they're measuring

Cumulative Procedure Time

Timeframe: 30 minutes

Trial details

NCT IDNCT06422312

SponsorGuangzhou Red Pine Medical Instrument Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01

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