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New penile implant aims to restore function for men with ED

NCT ID NCT05574868

Disease control Sponsor: Rigicon, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study is testing a new inflatable penile implant called the Rigicon Infla10 for men with erectile dysfunction. Researchers will implant the device in 182 men and follow them for up to 3 years to see if it is safe and works well. The main goal is to check if the implant helps men achieve a firm enough erection and does not cause serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rigicon Infla10 Three-Piece Inflatable Penile Prosthesis (a medical device implanted in the penis to help achieve an erection)
What this could lead to
If successful, this could provide a long-term, reliable treatment option for men with erectile dysfunction who have not responded to other therapies.
What could go wrong
This is a single-arm study with no comparison group, so results may be less definitive. Risks include infection, device malfunction, or need for revision surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 182 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advanced Urology Melbourne

    RECRUITING

    Malvern, Australia

  • Canberra Laparoscopic, Robotic & Laser Urology Centre

    RECRUITING

    Garran, Australia

  • Katelaris Urology

    RECRUITING

    Hornsby, Australia

  • Shire Urology

    RECRUITING

    Miranda, Australia

  • St George Urology

    RECRUITING

    Hurstville, Australia

  • Urology South at Holmesglen Private Hospital

    RECRUITING

    Moorabbin, Australia

  • Wesley Hospital

    RECRUITING

    Auchenflower, Australia

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