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RecruitingNCT07538622Updated Sep 1, 2026

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

An observational study in BPH (Benign Prostatic Hyperplasia), sponsored by Zenflow, Inc.. Recruiting at 8 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Zenflow, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • BPH (Benign Prostatic Hyperplasia)

Keywords

  • Benign Prostatic Hyperplasia (BPH)
  • Symptomatic BPH
  • BPH
  • Benign Prostatic Hyperplasia
  • enlarged prostate
  • lower urinary tract symptoms (LUTS)
  • LUTS
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DeviceZenflow Spring System

    Minimally Invasive Treatment for LUTS associated with BPH

05

What researchers measure

Primary outcomes

  1. Effectiveness - IPSS

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

    Time frame: Baseline to 12 Months

  2. Safety - adverse events

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

    Time frame: Baseline to 12 Months

06

Study locations

5 of 8 sites recruiting
  • Chopra Urology
    Phoenix, Arizona 85032, United States
    Not yet recruiting
  • San Diego Clinical Trials
    La Mesa, California 91942, United States
    Recruiting
  • Gulf Coast Clinical Trial Associates / Florida Urology Partners
    Tampa, Florida 33615, United States
    Recruiting
  • Avant Concierge Urology
    Winter Garden, Florida 34787, United States
    Recruiting
  • Dr Slade Urology
    Boise, Idaho 83704, United States
    Active, not recruiting
  • The Smith Institute of Urology/Northwell Health
    Syosset, New York 11791, United States
    • Jennifer Polo, Study Coordinator · Contact · jpolo1@northwell.edu · (516) 628-5910
    • Bilal Chughtai, MD · Principal investigator
    Recruiting
  • START Research
    Myrtle Beach, South Carolina 29572, United States
    Active, not recruiting
  • Midtown Urology Associates
    Austin, Texas 78705, United States
    • Study Coordinator · Contact · APBarger@cimplify.net · 512-451-7935
    • Tyler McClintock, MD · Principal investigator
    • Michael Trotter, MD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07538622
Lead sponsor
Zenflow, Inc.
Responsible party
Sponsor
First posted
Apr 20, 2026
Start date
Jul 29, 2026
Primary completion
Jul 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Sep 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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