RecruitingNot Applicable

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

United States182 participantsStarted 2026-01-26

Plain-language 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.

Who can participate

Age range22 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 for follow-up visits and tests.

Exclusion criteria

✕. 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.
✕. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
✕. Patients who are receiving chemotherapy at the time of enrolment.
✕. Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.
✕. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.

What they're measuring

The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v5.0 and IPP-specific mapping.

Timeframe: 12 months

The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 12 months.

Timeframe: 12 months

Trial details

NCT IDNCT07273773

SponsorRigicon, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Zeynep Tin Konukcu

888-202-9790 clinical@rigicon.com

View on ClinicalTrials.gov More Erectile Dysfunction (ED) trials

Plain-language summary

Who can participate

Age range22 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 for follow-up visits and tests.

Exclusion criteria

✕. 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.
✕. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
✕. Patients who are receiving chemotherapy at the time of enrolment.
✕. Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.
✕. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.

What they're measuring

Timeframe: 12 months

The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 12 months.

Timeframe: 12 months