A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms (NCT06849258)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Michael G Oefelein Clinical Trials โ Bakersfield, California
Age range: 45 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (20 Sites)
- Michael G Oefelein Clinical Trials โ Bakersfield, California
- Comprehensive Urology Medical Group โ Beverly Hills, California
- Atlas Men's Health โ La Mesa, California
- Urology Group of Southern California โ Los Angeles, California
- Alarcon Urology Center โ Montebello, California
- Prestige Medical Group โ Tustin, California
- Urology Denver โ Littleton, Colorado
- Advanced Urology Institute โ Daytona Beach, Florida
- Duly Health โ Lisle, Illinois
- Southern Urology โ Lafayette, Louisiana
- Michigan Institute of Urology โ Troy, Michigan
- Sheldon Freedman Urology โ Las Vegas, Nevada
- Manhattan Medical Research NYU Langone โ New York, New York
- Northwell Health โ Syosset, New York
- Associated Urologists of North Carolina โ Raleigh, North Carolina
- Conrad Pearson Clinic โ Germantown, Tennessee
- Midtown Urology Associates โ Austin, Texas
- Urology Austin/Urology America โ Austin, Texas
- Houston Methodist โ Houston, Texas
- South Coast Urology โ Wollongong, New South Wales
๐ Contact the Study Coordinator
Phone: (414) 758-7948
Email: info@rivermarkmedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocrossยฎ Expander System & Retrieval Sheath โ Maywood, Illinois
- Optilumeโข BPH Catheter System in Men With Symptomatic BPH โ Little Rock, Arkansas
- Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate โ Miami, Florida
- Laser Prostatectomy Database and Registry โ Indianapolis, Indiana
Explore by condition: All Benign Prostatic Hyperplasia clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.