Clinical Trial

Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)

Study acronym: ERASE-ED
Recruiting
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Summary
This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-08-14
notable Primary completion pushed: 2026-05-21 -> 2027-08-01 2026-08-14
minor Completion pushed: 2026-05-21 -> 2028-08-01 2026-08-14
Trial Details
NCT Number NCT05574868
Lead Sponsor Rigicon, Inc.
Conditions Erectile Dysfunction
Enrollment 182 participants
Start Date 2025-01-16
Primary Completion 2027-08-01 (estimated)
Study Completion 2028-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13