Could a dissolvable scaffold and your own fat replace silicone breast implants?

NCT ID NCT05437757

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 ยท Last updated Jul 10, 2026

Summary

This trial tests a new approach for women needing breast implant revision or correction of a congenital breast defect. Surgeons implant a 3D-printed, absorbable scaffold and inject the patient's own fat cells harvested from another body area. The scaffold acts as a temporary frame that dissolves over about three years, leaving behind the patient's natural tissue. The study aims to see if this method is safe and effective for regenerating soft breast tissue without a permanent implant.

What this could mean

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

Active substance
3D-printed polycaprolactone breast scaffold with autologous fat grafting
What this could lead to
If successful, this could offer a natural alternative to silicone implants for breast revision or congenital defect correction, using the body's own tissue.
What could go wrong
This is an early feasibility study with only 19 participants. The scaffold may not support adequate tissue growth, and risks include infection, fat absorption, or asymmetry.

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

19 people

The number who actually took part.

Started

Jun 2022

Finished

Dec 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.

Ages

18 years and older

Sex

Female 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. Females over the age of 18 requiring pre-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral. 2. Patient willing and able to comply with the study requirements. 3. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia). 4. Patient capable of providing valid informed consent. 5. Patient has sufficient body fat for homologous transplantation. Exclusion Criteria: 1. Patients who have undergone Radical Mastectomy or radical removal of chest wall soft tissue. 2. Patients who have had breast or chest wall irradiation. 3. Prior history of infection in the breast region in the preceding 12 months. 4. Patients diagnosed with or having a prior history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). 5. The patient has any condition or disease, including uncontrolled diabetes (e.g., HbA1c \> 8%), that is clinically known to impact wound healing ability. 6. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency. 7. Known severe concurrent or inter-current illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Co-ordinating Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results. 8. Body mass Index (BMI) below 20 and above 30 (patients with a BMI above 30 may still be eligible pending assessment by investigating team and documentation of rationale). 9. Polycaprolactone (PCL) allergy 10. Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the breast surgery. 11. Patient ineligible to undergo MRI. 12. Patient unable or unwilling to comply with the treatment protocol. 13. Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment. 14. Patients with a history of smoking (patients with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Royal Brisbane and Women's Hospital (RBWH)

    Brisbane, Queensland, QLD 4029, Australia

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