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A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
Sponsor: Rivermark Medical
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.
Official title: A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of The FloStent in Men Suffering From Benign Prostatic Hyperplasia Symptoms
Key Details
Gender
MALE
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
215
Start Date
2025-02-10
Completion Date
2032-12-31
Last Updated
2025-04-27
Healthy Volunteers
No
Conditions
Interventions
FloStent
Flexible cystoscopy to deploy medical device used to treat BPH
Sham (Control)
Flexible Cystoscopy without deployment of medical device used to treat BPH
Locations (20)
Michael G Oefelein Clinical Trials
Bakersfield, California, United States
Comprehensive Urology Medical Group
Beverly Hills, California, United States
Atlas Men's Health
La Mesa, California, United States
Urology Group of Southern California
Los Angeles, California, United States
Prestige Medical Group
Tustin, California, United States
Urology Denver
Littleton, Colorado, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Duly Health
Lisle, Illinois, United States
Loyola Medicine
Maywood, Illinois, United States
Southern Urology
Lafayette, Louisiana, United States
Michigan Institute of Urology
Troy, Michigan, United States
Sheldon Freedman Urology
Las Vegas, Nevada, United States
Manhattan Medical Research NYU Langone
New York, New York, United States
Northwell Health
Syosset, New York, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Conrad Pearson Clinic
Germantown, Tennessee, United States
Midtown Urology Associates
Austin, Texas, United States
Urology Austin/Urology America
Austin, Texas, United States
Houston Methodist
Houston, Texas, United States
South Coast Urology
Wollongong, New South Wales, Australia