Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry

N/ANot Yet RecruitingNCT07538622

Zenflow, Inc.300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

BPH (Benign Prostatic Hyperplasia)

Interventions

Zenflow Spring SystemDEVICE

Minimally Invasive Treatment for LUTS associated with BPH

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use Exclusion Criteria: * Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use

Locations (2)

San Diego Clinical Trials

La Mesa, California, United States

Midtown Urology Associates

Austin, Texas, United States

Outcomes

Primary Outcomes

Effectiveness - IPSS

The primary effectiveness endpoint is the change in IPSS from baseline over time

Time frame: Baseline to 12 Months

Safety - adverse events

The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs)

Time frame: Baseline to 12 Months