A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Benign Prostatic Hyperplasia
In brief
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.
Key facts
- Study ID
- NCT06849258
- Run by
- Rivermark Medical
- People needed
- 215
- Starts
- 2025-02-10
- Expected to finish
- 2032-12-31
- Last updated by the study team
- 2026-06-11
Who can join
Age: 45 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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)
Where it is running
- Michael G Oefelein Clinical Trials — Bakersfield, California, United States (enrolling)
- Comprehensive Urology Medical Group — Beverly Hills, California, United States (enrolling)
- Atlas Men's Health — La Mesa, California, United States (enrolling)
- Urology Group of Southern California — Los Angeles, California, United States (enrolling)
- Alarcon Urology Center — Montebello, California, United States (enrolling)
- Prestige Medical Group — Tustin, California, United States (enrolling)
- Urology Denver — Littleton, Colorado, United States (enrolling)
- Advanced Urology Institute — Daytona Beach, Florida, United States (enrolling)
- Duly Health — Lisle, Illinois, United States (enrolling)
- Southern Urology — Lafayette, Louisiana, United States (enrolling)
- Michigan Institute of Urology — Troy, Michigan, United States (enrolling)
- Sheldon Freedman Urology — Las Vegas, Nevada, United States (enrolling)
- Manhattan Medical Research NYU Langone — New York, New York, United States (enrolling)
- Northwell Health — Syosset, New York, United States (enrolling)
- Associated Urologists of North Carolina — Raleigh, North Carolina, United States (enrolling)
- Conrad Pearson Clinic — Germantown, Tennessee, United States (enrolling)
- Midtown Urology Associates — Austin, Texas, United States (enrolling)
- Urology Austin/Urology America — Austin, Texas, United States (enrolling)
- Houston Methodist — Houston, Texas, United States (enrolling)
- South Coast Urology — Wollongong, New South Wales, Australia (enrolling)
Full record on ClinicalTrials.gov
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