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Safety and Effectiveness Study of the Zenflow Spring System

NCT04987138 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2024-04-11

No results posted yet for this study

Summary

Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.

Conditions

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

Interventions

DEVICE

Zenflow Spring System

The Zenflow Spring Implant is an electropolished and passivated nickel titanium alloy (nitinol) implant. The implant is constructed from a single wire strand formed into ring elements connected by spine sections. There are four sizes of implants ranging from 16 mm to 24 mm in length and 14 mm to 16 mm in diameter to implant in the subject's prostatic urethra. The implant is placed in the urethra using a custom delivery catheter and cystoscope (Spring Scope). The implant is intended to be permanent but can be removed if necessary.

DEVICE

Sham Procedure

A18 Fr Foley Catheter is placed into the patient's bladder. To mimic the Treatment Arm procedure, the Foley Catheter balloon will be inflated in the bladder. Once inflated, slight tension will be applied against the subject's bladder neck. While tension is being applied the site staff will follow a script to simulate the Zenflow procedural steps. Additionally, devices will be used to produce mock deployment sounds of the Zenflow procedure. Once complete, the balloon will be deflated and the catheter will be removed, completing the procedure.

Sponsors & Collaborators

  • Zenflow, Inc.

    lead INDUSTRY

Principal Investigators

  • Claus Roehrborn, M.D · UT Southwestern, Dallas, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2024-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04987138 on ClinicalTrials.gov