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RECRUITING

NCT05574868

Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)

Sponsor: Rigicon, Inc.

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction

Key Details

Gender

MALE

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2022-07-11

Completion Date

2026-05-21

Last Updated

2025-12-05

Healthy Volunteers

Conditions

Erectile Dysfunction

Interventions

DEVICE

Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis

Treatment: Erectile dysfunction

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

Locations (7)

Wesley Hospital

Auchenflower, Australia

Canberra Laparoscopic, Robotic & Laser Urology Centre

Garran, Australia

Katelaris Urology

Hornsby, Australia

St George Urology

Hurstville, Australia

Advanced Urology Melbourne

Malvern, Australia

Shire Urology

Miranda, Australia

Urology South at Holmesglen Private Hospital

Moorabbin, Australia