Rigicon Infla10 inflatable penile prosthesis for erectile dysfunction

Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study

This trial will test the Rigicon Infla10 three-piece inflatable penile prosthesis in men with erectile dysfunction to see if it is safe and works well for up to three years after implantation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 22 Years and up
• Sex: Male
• Sponsor: Rigicon, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Coral Gables, Florida and 6 other locations)
• Trial ID: NCT07273773 on ClinicalTrials.gov

What this trial studies

The study follows men who receive the Rigicon Infla10 three-piece inflatable penile prosthesis and monitors device safety and performance for up to three years after surgery. Participants undergo baseline assessments, implantation using standard surgical technique, and scheduled follow-up visits that include device checks and patient-reported outcome measures. The study tracks device-related complications, functional outcomes, and durability over time. It is a multicenter, sponsor-led post-implant follow-up conducted at several U.S. urology centers.

Who should consider this trial

Good fit: Men aged 22 or older with a diagnosis of erectile dysfunction who agree to receive a three-piece Infla10 inflatable penile prosthesis and commit to the follow-up schedule are ideal candidates.

Not a fit: Patients with prior penile prostheses or enlargement surgeries, active fibrotic penile disease, uncontrolled diabetes, active chemotherapy or significant immunosuppression, contraindication to general anesthesia, or known allergy to device materials are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, the device could offer a durable surgical option to restore erectile function for men who have not had sufficient benefit from non-surgical therapies.

How similar studies have performed: Other three-piece inflatable penile prostheses from established manufacturers have a long track record of safety and effectiveness, though the Infla10 device is being studied specifically for its long-term performance.

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 for follow-up visits and tests.

Exclusion Criteria:

1. Contraindication to general anesthesia.
2. Known allergy or sensitivity to product materials as indicated in the device labeling.
3. Previous penile prosthesis or prior enlargement surgeries
4. Diagnosed penile sensory neuropathy.
5. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
6. Patients who are receiving chemotherapy at the time of enrolment.
7. Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.
8. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.
9. Uncontrolled diabetes (HbA1c ≥ 9.0% \[≈75 mmol/mol\], measured within 90 days prior to surgery.
10. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
11. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
12. Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \[serum creatinine \> 2.0 mg/dl\], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or in the judgment of the physician investigator preclude safe procedure.
13. Lacking manual dexterity or mental abilities necessary to operate the device.
14. Expected life expectancy \< two years.
15. Unwilling or unable to sign the Informed Consent.
16. Unwilling or unable to comply with the follow-up study requirements.
17. Psychogenic erectile dysfunction
18. Currently participating in an investigational drug or another investigational device exemption (IDE) study.
19. The cognitively challenged subjects and subjects with any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study questionnaires.
20. Incarcerated subjects
21. Subjects who are currently using, or who have not previously attempted and failed, standard non-surgical ED therapies including oral or topical treatments.

Where this trial is running

Coral Gables, Florida and 6 other locations

• Perito Urology — Coral Gables, Florida, United States (Recruiting)
• Atlanta Cosmetic Urology — Atlanta, Georgia, United States (Recruiting)
• UroPartners — Chicago, Illinois, United States (Not_yet_recruiting)
• Kramer Urology — Hyannis, Massachusetts, United States (Not_yet_recruiting)
• Washington Heights Urology — New York, New York, United States (Recruiting)
• Urology Partners of North Texas — Arlington, Texas, United States (Not_yet_recruiting)
• Vitality Urology Institute — Houston, Texas, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Zeynep Tin Konukcu

Conditions Erectile Dysfunction; Rigicon; Infla10; inflatable penile prosthesis; penile prosthesis; Dynamic; erectile dysfunction