🏛️ Verified NIH Record • Updated 2026-08-11

Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction (NCT07273773)

Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study

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

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

This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.

Who can join: Review the eligibility criteria below.

Location: Perito Urology — Coral Gables, Florida

Age range: 22 Years

📋 "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 (4 Sites)

  • Perito Urology — Coral Gables, Florida
  • The University of South Florida Board of Trustees / Tampa General Hospital — Tampa, Florida
  • Atlanta Cosmetic Urology — Atlanta, Georgia
  • Vitality Urology Institute — Houston, Texas

📞 Contact the Study Coordinator

Phone: (888) 202-9790

Email: clinical@rigicon.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.

More studies in Erectile Dysfunction (ED)

💡 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 ↗