RecruitingNot ApplicableNCT07273773

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

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

Sponsor

Rigicon, Inc.

Enrollment

182 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Erectile Dysfunction (ED)

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

Sex: MALEMin Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for people with erectile dysfunction (ed). The study is currently recruiting participants at 7 locations. People eligible for this study include men aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERigicon Infla10® Inflatable Penile Prosthesis (IPP)

Medical Device: Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis • Other Names: Inflatable Penile Prosthesis (IPP) Treatment: Erectile dysfunction

Locations(4)

Perito Urology

Coral Gables, Florida, United States

The University of South Florida Board of Trustees / Tampa General Hospital

Tampa, Florida, United States

Atlanta Cosmetic Urology

Atlanta, Georgia, United States

Vitality Urology Institute

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07273773

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