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New penile implant study shows promise for Men's confidence

NCT ID NCT04985123

Disease control Sponsor: International Medical Devices, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a silicone block placed under the skin of the penis to improve its size, shape, and appearance. It included 40 men who were unhappy with their penile girth or length. The main goal was to check safety and measure changes in size and patient satisfaction.

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.

Participants

40 people

The number who actually took part.

Started

Jul 2021

Finished

Apr 2025

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.

Who is studied

All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.

Ages

18 to 65 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Inclusion criteria include men who are over 18 and under 65, circumcised, who have the perception of inadequate penile girth or appearance of length of penis, or penile deviation from straight plane in flaccid condition for whatever reason. Etiologies may include: * A retractile penis or "buried penis" from infrapubic pannus * A loss of length following radical prostatectomy or other trauma * Congenital or acquired (e.g., Peyronie's Disease) mild curvature of the penis with indentation deformity and with curvature less than 30 degrees with no plan to have other corrective procedures (e.g. surgery, intralesional injection of collagenase clostridium histolyticum) * Patient perception of a penis of inadequate size and patient desire for cosmetic enhancement Exclusion Criteria: * Men who are unable to give informed consent * An uncircumcised penis * Micro-penis (stretched flaccid penile length \<6cm) * Prior penile girth enhancement procedure of any sort, including grafts or subcutaneous injections, previous Xiaflex injection * History of immunosuppression and/or HIV * Men who are on anti-coagulation medication which cannot be stopped * Uncontrolled diabetes * Active genitourinary skin infection * History of recurrent or active urinary tract infection (UTI) * Patients unwilling to comply with post-operative instructions * Patients who smoke and are unwilling to stop 2 weeks before surgery and for at least 6 weeks after surgery.

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Conditions

The condition(s) this trial relates to.

Peyronie disease

As listed by the trial registrant

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

Penile implant

Contacts and locations

Locations

  • Uropartners

    Chicago, Illinois, 60612, United States