Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Urotronic Inc.
- Study ID
- NCT06312722
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Optilume® BPH Catheter System — DEVICEThe Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Study Details
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Key Dates
- Start date
- Feb 7, 2024
- Status verified
- Jan 2026
- Primary completion
- Feb 7, 2031
- Completion
- Feb 7, 2031
Study Design
- Enrollment
- 92 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Study ArmOptilume BPH Catheter System
Primary Outcome Measure
Change in International Prostate Symptom Score (IPSS) [ Time Frame: Baseline to 12 months ]
Central Contacts
- Jill Moland612-245-6434
- Brandon Shuler701-220-1710
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arkansas Urology | Little Rock | Arkansas | 72211 | Jeffrey Marotte, MD (PRINCIPAL_INVESTIGATOR) |
| Florida Urology Partners, LLP | Tampa | Florida | 33615 | Osvaldo Padron, MD (PRINCIPAL_INVESTIGATOR) |
| Ochsner LSU Health Shreveport - Regional Urology | Shreveport | Louisiana | 71106 | Jared Moss, MD (PRINCIPAL_INVESTIGATOR) |
| Sheldon Freedman MD, Ltd | Las Vegas | Nevada | 89144 | Sheldon Freedman, MD (PRINCIPAL_INVESTIGATOR) |
| Midtown Urology Associates | Austin | Texas | 78705 | Michael Trotter, MD (PRINCIPAL_INVESTIGATOR) |
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