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

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.

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Key information

Conditions

BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Chopra Urology, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zenflow Spring System

Device

Minimally Invasive Treatment for LUTS associated with BPH

Primary outcomes

Effectiveness - IPSS

Time frame: Baseline to 12 Months

The primary effectiveness endpoint is the change in IPSS from baseline over time
Safety - adverse events

Time frame: Baseline to 12 Months

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

Sponsors and collaborators

Lead sponsor

Zenflow, Inc.

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Apr 20, 2026
Registry last updated: Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting