New penile implant aims to restore function for men with ED

NCT ID NCT05574868

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••
Contact

Phone: •••-•••-•••• 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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