Trials / Withdrawn
WithdrawnNCT06422312
A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.
Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Guangzhou Red Pine Medical Instrument Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cystoscopy with RedPine flexible disposable cystoscope | Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents. |
| DEVICE | Cystoscopy with standard of care flexible reusable scope | Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents |
Timeline
- Start date
- 2024-10-01
- Primary completion
- 2025-01-01
- Completion
- 2025-07-01
- First posted
- 2024-05-20
- Last updated
- 2025-04-04
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06422312. Inclusion in this directory is not an endorsement.