NCT05574868 Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
| NCT ID | NCT05574868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigicon, Inc. |
| Condition | Erectile Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2022-07-11 |
| Primary Completion | 2026-05-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 182 participants in total. It began in 2022-07-11 with a primary completion date of 2026-05-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.
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. 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
Contact & Investigator
Chris Love, Dr.
PRINCIPAL INVESTIGATOR
Urology South at Holmesglen Private Hospital
Frequently Asked Questions
Who can join the NCT05574868 clinical trial?
This trial is open to male participants only, aged 22 Years or older, studying Erectile Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05574868 currently recruiting?
Yes, NCT05574868 is actively recruiting participants. Contact the research team at clinical@rigicon.com for enrollment information.
Where is the NCT05574868 trial being conducted?
This trial is being conducted at Auchenflower, Australia, Garran, Australia, Hornsby, Australia, Hurstville, Australia and 3 additional locations.
Who is sponsoring the NCT05574868 clinical trial?
NCT05574868 is sponsored by Rigicon, Inc.. The principal investigator is Chris Love, Dr. at Urology South at Holmesglen Private Hospital. The trial plans to enroll 182 participants.