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

NCT07538622 | Not Yet Recruiting FDA Device

• 1 other identifier: CLIN-0297
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

Benign Prostatic Hyperplasia (BPH); Symptomatic BPH; BPH; Benign Prostatic Hyperplasia; enlarged prostate; lower urinary tract symptoms (LUTS); LUTS

Outcome Measures

Primary Outcomes (2)

• Effectiveness - IPSS

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

  Baseline to 12 Months

• Safety - adverse events

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

  Baseline to 12 Months

Interventions

Zenflow Spring System DEVICE

Minimally Invasive Treatment for LUTS associated with BPH

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.

You may qualify if:

• Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use

You may not qualify if:

• Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use

Sponsors & Collaborators

• Zenflow, Inc.: lead

Study Sites (2)

San Diego Clinical Trials

La Mesa, California, 91942, United States

Location

Midtown Urology Associates

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)