Evaluation of a new 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

This study assesses the long-term safety and effectiveness of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in men diagnosed with erectile dysfunction. Participants will be followed for up to three years post-implantation, with evaluations occurring at multiple intervals to monitor outcomes. The study aims to provide insights into the prosthesis's performance and its impact on patients' quality of life. The research involves a structured follow-up protocol to ensure comprehensive data collection and patient care.

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 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. Diagnosed with fibrotic disease, such as priapism, Peyronie's disease or Chordee.
6. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
7. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation
8. Uncontrolled diabetes (Fasting Blood Sugar FBS) \>300 or HbA1c ≥9.0 on morning of surgery)
9. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
10. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
11. 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.
12. 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.
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. Currently participating in an investigational drug or another investigational device exemption (IDE) study.
18. Incarcerated subjects
19. Psychogenic erectile dysfunction

Where it's running

• Wesley Hospital
  Auchenflower, Australia Recruiting
• Canberra Laparoscopic, Robotic & Laser Urology Centre
  Garran, Australia Recruiting
• Katelaris Urology
  Hornsby, Australia Recruiting
• St George Urology
  Hurstville, Australia Recruiting
• Advanced Urology Melbourne
  Malvern, Australia Recruiting
• Shire Urology
  Miranda, Australia Recruiting

Study contacts

• Principal investigator: Chris Love, Dr. — Urology South at Holmesglen Private Hospital
• Study coordinator: Zeynep Tin Konukcu
• Email: clinical@rigicon.com
• Phone: 888-202-9790

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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.