Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
Led by Rivermark Medical · Updated on 2025-04-27
215
Participants Needed
20
Research Sites
411 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Michael G Oefelein Clinical Trials
Bakersfield, California, United States, 93301
Actively Recruiting
2
Comprehensive Urology Medical Group
Beverly Hills, California, United States, 90048
Actively Recruiting
3
Atlas Men's Health
La Mesa, California, United States, 91942
Actively Recruiting
4
Urology Group of Southern California
Los Angeles, California, United States, 90017
Actively Recruiting
5
Prestige Medical Group
Tustin, California, United States, 92780
Actively Recruiting
6
Urology Denver
Littleton, Colorado, United States, 80122
Actively Recruiting
7
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
Actively Recruiting
8
Duly Health
Lisle, Illinois, United States, 60532
Actively Recruiting
9
Loyola Medicine
Maywood, Illinois, United States, 60153
Not Yet Recruiting
10
Southern Urology
Lafayette, Louisiana, United States, 70508
Actively Recruiting
11
Michigan Institute of Urology
Troy, Michigan, United States, 48084
Actively Recruiting
12
Sheldon Freedman Urology
Las Vegas, Nevada, United States, 89144
Actively Recruiting
13
Manhattan Medical Research NYU Langone
New York, New York, United States, 10016
Actively Recruiting
14
Northwell Health
Syosset, New York, United States, 11791
Not Yet Recruiting
15
Associated Urologists of North Carolina
Raleigh, North Carolina, United States, 27612
Actively Recruiting
16
Conrad Pearson Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
17
Midtown Urology Associates
Austin, Texas, United States, 78705
Actively Recruiting
18
Urology Austin/Urology America
Austin, Texas, United States, 78759
Actively Recruiting
19
Houston Methodist
Houston, Texas, United States, 77030
Not Yet Recruiting
20
South Coast Urology
Wollongong, New South Wales, Australia, 2500
Not Yet Recruiting
Research Team
S
Study Manager Study Director, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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