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NCT06849258NARecruiting

A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

Rivermark Medical

Start Date

2/10/2025

Completion Date

12/31/2032

Summary

The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.

Eligibility Criteria

Age Range: 45 years to No maximum

Inclusion Criteria: * Male subjects \> 45 years of age who have symptomatic BPH * International Prostate Symptom Score (IPSS) score \>13 * Peak urinary flow rate (Qmax): \>5 mL/sec and \<13 mL/sec with minimum voided volume of \>125 mL * Post-void residual (PVR) \<250 mL * Prostate volume 25 to 80 mL * Prostatic urethral length 20-50 mm * Able to complete the study protocol and visits Exclusion Criteria: * Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate * Prior minimally invasive intervention or surgical intervention of the prostate or urethra * PSA \>10 ng/mL * Bladder cancer or bladder stones * Active urinary tract infection (UTI) * Uncontrolled diabetes * Part of a vulnerable population (cognitively challenged or are incarcerated)

Interventions

DEVICE

FloStent

DEVICE

Sham (Control)

Interested in This Trial?

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Conditions

Benign Prostatic Hyperplasia

Locations

Michael G Oefelein Clinical Trials

Bakersfield, California 93301

United States

Comprehensive Urology Medical Group

Beverly Hills, California 90048

United States

Atlas Men's Health

La Mesa, California 91942

United States

Urology Group of Southern California

Los Angeles, California 90017

United States

Alarcon Urology Center

Montebello, California 90640

United States

Prestige Medical Group

Tustin, California 92780

United States

Urology Denver

Littleton, Colorado 80122

United States

Advanced Urology Institute

Daytona Beach, Florida 32114

United States

Duly Health

Lisle, Illinois 60532

United States

Southern Urology

Lafayette, Louisiana 70508

United States

Michigan Institute of Urology

Troy, Michigan 48084

United States

Sheldon Freedman Urology

Las Vegas, Nevada 89144

United States

Manhattan Medical Research NYU Langone

New York, New York 10016

United States

Northwell Health

Syosset, New York 11791

United States

Associated Urologists of North Carolina

Raleigh, North Carolina 27612

United States

Conrad Pearson Clinic

Germantown, Tennessee 38138

United States

Midtown Urology Associates

Austin, Texas 78705

United States

Urology Austin/Urology America

Austin, Texas 78759

United States

Houston Methodist

Houston, Texas 77030

United States

South Coast Urology

Wollongong, New South Wales 2500

Australia