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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

NCT04987138•Zenflow, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Subject is able and willing to comply with all the assessments of the study,
•2. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form,
•3. ≥ 45 years of age,
•4. Baseline IPSS score ≥ 13; ≥ 1 in the IPSS voiding to storage sub-score ratio (IPSS-V/S),
•5. Prostate volume 25 - 80 cc by transrectal ultrasound (TRUS), measured within 120 days post study consent,
•6. Prostatic urethral length between 25 and 45 mm, as measured by cystoscopic pull-back,
•7. Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.

Exclusion Criteria

•1. Obstructive intravesical median prostatic lobe as determined by ultrasound (i.e., more than 10 mm intravesical prostatic protrusion on sagittal mid-prostate plane via abdominal ultrasound),
•2. High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator,
•3. Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent,
•4. Anatomical anomalies that will not accommodate the Implant, as determined by cystoscopy (e.g., prostatic urethral length to height geometry),
•5. Requires indwelling catheter or intermittent catheterization to void,
•6. Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction),
•7. One of the following baseline test results, taken from a single uroflowmetry reading:
•1. Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required),
•2. Peak urinary flow rate (Qmax) of ≤ 5 ml/second or \> 15 mL/second,
•3. Post- void residual volume (PVR) \> 250 mL
+25 more criteria

Locations (7)

American Institute of Research

Los Angeles, California, United States

Northshore University Health System

Glenview, Illinois, United States

Sheldon Freedman, MD, LTD

Las Vegas, Nevada, United States

Carolina Urologic Research Associates

Myrtle Beach, South Carolina, United States

Midtown Urology Associates

Austin, Texas, United States

Urology Austin, PLLC

Austin, Texas, United States

Urology of Virginia, PLLC

Virginia Beach, Virginia, United States

Key Dates

Start Date

September 30, 2021

Primary Completion Date

June 30, 2024

Completion Date

June 1, 2026

Last Updated

April 11, 2024

Enrollment

279

ESTIMATED participants

Conditions

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

Interventions

Zenflow Spring System

DEVICE

Sham Procedure

DEVICE

RCT on Running Water Sound During Urodynamic

NCT07451548

Lower Urinary Tract Symptoms (LUTS)

View study

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

RT-310 Safety and Feasibility BPH Study

NCT07264205

BPH (Benign Prostatic Hyperplasia)

View study

ACTIVE_NOT_RECRUITINGPHASE1

RT-310 Dose Escalation BPH Study

NCT06136819

BPH (Benign Prostatic Hyperplasia)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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