Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
Recruiting
N/A
Interventional Study
Erectile Dysfunction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 and older
- Sex
- Male
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 182 (estimated)
- Sponsor
- Rigicon, Inc. · Industry
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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 week…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male ≥22 years of age.
2. Diagnosed with erectile dysfunction (impotence).
3. Agree to receive Infla10® three-piece IPP as an ED treatment.
4. Willing to complete all protocol required follow-up visits and tests.
Exclusion Criteria:
1. Contraindication to general anesthesia…
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