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 — DEVICE
    Minimally 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)

FacilityCityStateZIPSite coordinators
San Diego Clinical TrialsLa MesaCalifornia91942-
Midtown Urology AssociatesAustinTexas78705
Andrew Barger
512-451-7935
Tyler McClintock, MD (PRINCIPAL_INVESTIGATOR)
Michael Trotter, MD (SUB_INVESTIGATOR)

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