Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry
Part of paid clinical trials in La Mesa, California.
- Sponsor
- Zenflow, Inc.
- Study ID
- NCT07538622
- Status
- Not Yet Recruiting
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Conditions
- BPH (Benign Prostatic Hyperplasia)
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Zenflow Spring System — DEVICEMinimally Invasive Treatment for LUTS associated with BPH
Study Details
The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2028
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 300 participants (estimated)
Primary Outcome Measure
Effectiveness - IPSS [ Time Frame: Baseline to 12 Months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Diego Clinical Trials | La Mesa | California | 91942 | - |
| Midtown Urology Associates | Austin | Texas | 78705 | Tyler McClintock, MD (PRINCIPAL_INVESTIGATOR) Michael Trotter, MD (SUB_INVESTIGATOR) |
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