A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
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
Interventions
FloStent
Sham (Control)
Conditions
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