The study of Rigicon Infla10® three piece inflatable penile prosthesis (ERASE ED)
Rigicon, Inc is recruiting patients for the clinical trial of Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED).
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, 1 month, 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.
A patient-activated inflatable penile prosthesis (IPP) provides patients a means to achieve dependable spontaneity for intercourse. Rigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This proposed study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including biocompatibility, device validation and verification, and animal studies support the safety and efficacy of this device for the intended therapy.
Among primary outcome measures are the Survival at 12 months and Freedom from surgical revision at 12 months post-procedure.
The study will take place at the Dr. Paul Perito / Perito Urology, Coral Gables, Florida, United States; University of Health Sciences,Turkey Haydarpasa Numune Research and Training Hospital, Istanbul, Tıbbiye Cad. No: 23, Turkey.
Included will be male ≥21 years of age diagnosed with erectile dysfunction (impotence) that will agree to receive Infla10® three-piece IPP as an ED treatment and are willing to complete all protocol required follow-up visits and tests, without contraindication to general anesthesia.
The following page providea a detailed overview of the inclusion and exclusion criteria, and the contact details of study centers: https://ichgcp.net/clinical-trials-registry/NCT05574868.
