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RECRUITING
NCT06849258
NA

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

Sponsor: Rivermark Medical

View on ClinicalTrials.gov

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

Interventions

DEVICE

FloStent

Flexible cystoscopy to deploy medical device used to treat BPH

DEVICE

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