RecruitingNot ApplicableNCT05574868

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

Evaluation of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction


Sponsor

Rigicon, Inc.

Enrollment

182 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and performance of the Infla10 three-piece inflatable penile prosthesis — a surgically implanted device used to treat erectile dysfunction (ED). The device works like a pump system inside the body that allows a man to achieve an erection when desired. You may be eligible if: - You are a male aged 22 or older - You have been diagnosed with erectile dysfunction - You agree to receive the Infla10 implant as your ED treatment - You are willing to attend all required follow-up visits You may NOT be eligible if: - You have a contraindication to general anesthesia - You are allergic to any device materials - You have had a previous penile implant or enlargement surgery - You have penile sensory nerve damage, Peyronie's disease, priapism, or chordee - You have a compromised immune system (e.g., lupus, scleroderma) - You take immunosuppressive drugs or have had a kidney transplant - Your diabetes is poorly controlled (fasting blood sugar above 300 or HbA1c 9.0 or more on surgery morning) - You have a bleeding disorder, active infection, or major untreated health conditions - Your ED is purely psychological (psychogenic) - Your life expectancy is less than 2 years Talk to your doctor to see if this trial is right for you.

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 Infla 10® Three-Piece Inflatable Penile Prosthesis

Treatment: Erectile dysfunction


Locations(7)

Wesley Hospital

Auchenflower, Australia

Canberra Laparoscopic, Robotic & Laser Urology Centre

Garran, Australia

Katelaris Urology

Hornsby, Australia

St George Urology

Hurstville, Australia

Advanced Urology Melbourne

Malvern, Australia

Shire Urology

Miranda, Australia

Urology South at Holmesglen Private Hospital

Moorabbin, Australia

View Full Details on ClinicalTrials.gov

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NCT05574868


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