Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 22
Healthy Volunteers: f
View:
• Male ≥22 years of age.
• Diagnosed with erectile dysfunction (impotence).
• Agree to receive Infla10® three-piece IPP as an ED treatment.
• Willing to complete all protocol required for follow-up visits and tests.
Locations
United States
Florida
Perito Urology
RECRUITING
Coral Gables
Georgia
Atlanta Cosmetic Urology
RECRUITING
Atlanta
Illinois
UroPartners
NOT_YET_RECRUITING
Chicago
Massachusetts
Kramer Urology
NOT_YET_RECRUITING
Hyannis
New York
Washington Heights Urology
RECRUITING
New York
Texas
Urology Partners of North Texas
NOT_YET_RECRUITING
Arlington
Vitality Urology Institute
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Zeynep Tin Konukcu
clinical@rigicon.com
888-202-9790
Time Frame
Start Date: 2026-01-26
Estimated Completion Date: 2029-07
Participants
Target number of participants: 182
Treatments
Experimental: Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis
Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.
Related Therapeutic Areas
Sponsors
Leads: Rigicon, Inc.