Rigicon Infla10 inflatable penile prosthesis for erectile dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Perito Urology
  Coral Gables, Florida, United States Recruiting
• The University of South Florida Board of Trustees / Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Atlanta Cosmetic Urology
  Atlanta, Georgia, United States Recruiting
• Vitality Urology Institute
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Zeynep Tin Konukcu
• Email: clinical@rigicon.com
• Phone: 888-202-9790

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venous leakage ED: embolosclerotherapy vs deep dorsal vein revascularization

  This trial tests whether embolizing the veins around the penis or reconstructing the deep dorsal vein helps men with erectile dysfunction caused by venous leaks.

  Recruiting Mansoura University Hospital · Al Mansurah, Dakahlia Governorate · NCT07604194

• Intraurethral Alprostadil Paste for Erectile Dysfunction: Dose-Escalation Study

  A 12-week, dose-escalation study tests a new alprostadil paste applied inside the urethra to see if it improves erections in men with ED who have not benefited from PDE5 inhibitors.

  Recruiting Phase 2 University of British Columbia · Vancouver, British Columbia · NCT07601646

• Evaluation of a new inflatable penile prosthesis for erectile dysfunction

  This study is testing a new inflatable penile implant to see if it safely helps men with erectile dysfunction feel better over the long term.

  Recruiting at 7 sites Rigicon, Inc. · Auchenflower and 6 other locations · NCT05574868

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.