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
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Michael G Oefelein Clinical Trials
RECRUITING
Bakersfield
Comprehensive Urology Medical Group
RECRUITING
Beverly Hills
Atlas Men's Health
RECRUITING
La Mesa
Urology Group of Southern California
RECRUITING
Los Angeles
Prestige Medical Group
RECRUITING
Tustin
Colorado
Urology Denver
RECRUITING
Littleton
Florida
Advanced Urology Institute
RECRUITING
Daytona Beach
Illinois
Duly Health
RECRUITING
Lisle
Loyola Medicine
NOT_YET_RECRUITING
Maywood
Louisiana
Southern Urology
RECRUITING
Lafayette
Michigan
Michigan Institute of Urology
RECRUITING
Troy
North Carolina
Associated Urologists of North Carolina
RECRUITING
Raleigh
Nevada
Sheldon Freedman Urology
RECRUITING
Las Vegas
New York
Manhattan Medical Research NYU Langone
RECRUITING
New York
Northwell Health
NOT_YET_RECRUITING
Syosset
Tennessee
Conrad Pearson Clinic
RECRUITING
Germantown
Texas
Midtown Urology Associates
RECRUITING
Austin
Urology Austin/Urology America
RECRUITING
Austin
Houston Methodist
NOT_YET_RECRUITING
Houston
Other Locations
Australia
South Coast Urology
NOT_YET_RECRUITING
Wollongong
Contact Information
Primary
Study Manager Study Director, MD
info@rivermarkmedical.com
414-758-7948
Time Frame
Start Date:2025-02-10
Estimated Completion Date:2032-12-31
Participants
Target number of participants:215
Treatments
Experimental: Treatment - FloStent
Flexible cystoscopy procedure with FloStent implant deployed
Sham_comparator: Sham Control
Flexible cystoscopy procedure without FloStent implant deployed