🏛️ Verified NIH Record • Updated 2026-07-08

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study (NCT06312722)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Urotronic Inc.

🩺 Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Who can join: Review the eligibility criteria below.

Location: Arkansas Urology — Little Rock, Arkansas

Age range: 50 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (7 Sites)

  • Arkansas Urology — Little Rock, Arkansas
  • Florida Urology Partners, LLP — Tampa, Florida
  • Ochsner LSU Health Shreveport - Regional Urology — Shreveport, Louisiana
  • Sheldon Freedman MD, Ltd — Las Vegas, Nevada
  • Oregon Urology Institute — Springfield, Oregon
  • Midtown Urology Associates — Austin, Texas
  • Houston Methodist Urology Associates — Houston, Texas

📞 Contact the Study Coordinator

Phone: (612) 816-0068

Email: kpalm@laborie.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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 § 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗