Clinical trial Recruiting at 5 sites Observational Ages 18 and up Men only

Zenflow Spring System in everyday use for enlarged prostate

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

Run by Zenflow, Inc. · NCT07538622 · Data updated 2026-11-12

This registry tests how the Zenflow Spring System works for men with BPH in routine clinical settings and follows patients for 12 months after implantation.

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment300 (estimated)
SponsorZenflow, Inc.
Industry-sponsored
Locations8 sites (Phoenix, Arizona and 7 other locations)
StatusRecruiting
StartedJuly 29, 2026
Main results expectedJuly 2028
Study endsSeptember 2028
Registry record updatedSeptember 1, 2026
Trial IDNCT07538622 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with symptomatic BPH who are treated with the Zenflow Spring System according to the device’s approved instructions for use.

Probably not a fit

Patients may not experience symptom relief or may encounter adverse events related to the device.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, post-market registry evaluating the Zenflow Spring System for treating lower urinary tract symptoms due to BPH. It collects real-world data during the implant procedure and at 1, 3, 6, and 12 months of follow-up to assess symptom changes, return to daily activities, patient satisfaction, and any device-related problems or side effects. The study observes how the device performs in typical clinical practice across participating sites. It does not randomize patients or compare with another treatment as part of its design. The emphasis is on safety, usability, and practical outcomes in routine care.

Why it matters

Potential benefit: If successful, the registry could confirm real‑world safety and practicality of the Zenflow Spring System and demonstrate its impact on LUTS symptoms and patient quality of life.

How similar studies have gone: Post-market registries for similar minimally invasive devices have provided useful real-world safety and performance data, though results can vary by setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • San Diego Clinical Trials
    La Mesa, California, United States
    Recruiting
  • Gulf Coast Clinical Trial Associates / Florida Urology Partners
    Tampa, Florida, United States
    Recruiting
  • Avant Concierge Urology
    Winter Garden, Florida, United States
    Recruiting
  • The Smith Institute of Urology/Northwell Health
    Syosset, New York, United States
    Recruiting
  • Midtown Urology Associates
    Austin, Texas, United States
    Recruiting
  • Chopra Urology
    Phoenix, Arizona, United States
    Not yet recruiting
Show 2 more locations
  • Dr Slade Urology
    Boise, Idaho, United States
    Active not recruiting
  • START Research
    Myrtle Beach, South Carolina, United States
    Active not recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.