Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
ConditionErectile Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age22+
SponsorRigicon, Inc.
About this trial
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 criteria
Qualifiers
Male ≥22 years of age.
Diagnosed with erectile dysfunction (impotence).
Agree to receive Infla10® three-piece IPP as an ED treatment.
Willing to complete all protocol required follow-up visits and tests.
Disqualifiers
1. Contraindication to general anesthesia.
Known allergy or sensitivity to product materials as indicated in the device labeling.
Previous penile prosthesis or prior enlargement surgeries
Diagnosed penile sensory neuropathy.
Trial design
Treatments tested in this trial
- Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Treatment groups
182 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov