Clinical Trial

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

Study acronym: UNITED
Recruiting
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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.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-08-14
notable Trial sites reduced: 7 -> 4 locations 2026-08-14
Trial Details
NCT Number NCT07273773
Lead Sponsor Rigicon, Inc.
Conditions Erectile Dysfunction (ED)
Enrollment 182 participants
Start Date 2026-01-26
Primary Completion 2027-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-13