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

Last updated: August 11, 2026
Sponsor: Rigicon, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Impotence

Erectile Dysfunction

Treatment

Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis

Clinical Study ID

NCT05574868
RC2024V5
  • Ages > 22
  • Male

Study 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

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

Exclusion Criteria:

  1. Contraindication to general anesthesia.

  2. Known allergy or sensitivity to product materials as indicated in the devicelabeling.

  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, orscleroderma

  7. Patients who are receiving immunosuppressive drugs or have a history of kidneytransplantation

  8. Uncontrolled diabetes (Fasting Blood Sugar FBS) >300 or HbA1c ≥9.0 on morning ofsurgery)

  9. Bleeding disorder or coagulopathy that may in the judgment of the investigatorpreclude safe procedure.

  10. Active urogenital infection or active skin infection in region of surgery orsystemic 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, bleedingdisorders, or metabolic impairment) that may confound the results of the study or inthe judgment of the physician investigator preclude safe procedure.

  12. Any cognitive disorder that interferes with or precludes direct and accuratecommunication with the study investigator regarding the study or affects the abilityto 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 deviceexemption (IDE) study.

  18. Incarcerated subjects

  19. Psychogenic erectile dysfunction

Study Design

Total Participants: 182
Treatment Group(s): 1
Primary Treatment: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Phase:
Study Start date:
January 16, 2025
Estimated Completion Date:
August 01, 2028

Study Description

Erectile dysfunction (ED) is a common male sexual dysfunction associated with a reduced quality of life for patients and their partners. Incidence of ED increases with age and is associated with depression, obesity, diabetes mellitus, hypertension, cardiovascular disease and benign prostatic hyperplasia. ED is diagnosed with symptoms of (1) inability to attain or sustain a penile erection during sexual activity and (2) a reduction of penile rigidity in >75% of sexual encounters during six months period. ED is estimated to affect approximately 52% of men in age of 40 to 70 years.It is projected in 2025, the worldwide ED prevalence of about 322 million. ED usually has organic causes, such as damage of arteries, smooth muscle and fibrous tissue. This resuls in impairment of blood flow to and from penis due to diabetes, renal disease, atherosclerosis and vascular disease.

Management of ED involves in life style modification, medical, surgical interventions, and possibly, in the future, tissue- engineering or cellular or gene therapy. Oral phosphodiesterase type 5 inhibitor (PDE5i), which works with sexual stimulation, is an effective medical therapy for ED with an excellent safety profile. Intracavernosal injection of or topical application vasoactive drug have also been studied. The first inflatable penile prosthesis was introduced in 1973 and current models of inflatable penile prostheses include the AMS 700 series, and Coloplast Titan device. A patient-activated inflatable penile prosthesis (IPP) provides patients a means to achieve dependable spontaneity for intercourse.

Rigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This proposed study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including biocompatibility, device validation and verification, and animal studies support the safety and efficacy of this device for the intended therapy.

Connect with a study center

  • Wesley Hospital

    Auchenflower,
    Australia

    Active - Recruiting

  • Canberra Laparoscopic, Robotic & Laser Urology Centre

    Garran,
    Australia

    Active - Recruiting

  • Katelaris Urology

    Hornsby,
    Australia

    Active - Recruiting

  • St George Urology

    Hurstville,
    Australia

    Active - Recruiting

  • Advanced Urology Melbourne

    Malvern,
    Australia

    Active - Recruiting

  • Shire Urology

    Miranda,
    Australia

    Active - Recruiting

  • Urology South at Holmesglen Private Hospital

    Moorabbin,
    Australia

    Active - Recruiting

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