NCT04987138

Safety and Effectiveness Study of the Zenflow Spring System

Safety and Effectiveness Study of the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (estimated)
• Sponsor: Zenflow, Inc. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Prospective, multi-center, multinational, 2:1 randomized, single-blinded, controlled clinical trial of the Zenflow Spring System. Patients randomized to the treatment group will undergo Zenflow Spring placement. Patients randomized to the control group will undergo a Sham procedure. Patients and site personnel administering follow-up assessments will be blinded to the randomized treatment through completion of the 3-month follow-up visit. Once a patient has completed their 3-month follow-up assessments, they will be unblinded. Following unblinding, patients who received a Sham procedure may elect to receive treatment with the Zenflow Spring System or alternatively they may exit the study. The duration of study participation is 60 months for patients who receive a Spring Implant and 3 months for subjects in the Control Arm.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-30
• Primary completion: 2024-06-30
• Completion: 2026-06-01
• First posted: 2021-08-03
• Last updated: 2024-04-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study