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

NCT07797348 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-09-01

No results posted yet for this study

Summary

This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe LUTS/BPH. Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria.

Conditions

  • Benign Prostatic Hyperplasia (BPH)
  • Obstructive Lower Urinary Tract Symptoms (LUTS)
  • Enlarged Prostate

Interventions

DEVICE

Zenflow Arm: Zenflow Spring System implant procedure

The Zenflow Spring Implant is designed to be a permanent implant but can be repositioned or removed by the physician.

DRUG

Medical Therapy Tamsulosin

Tamsulosin is a prescription medicine that relaxes the muscles around the prostate and bladder to help men with an enlarged prostate (BPH) urinate more easily

Sponsors & Collaborators

  • Zenflow, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-01
Completion
2029-09-01
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797348 on ClinicalTrials.gov