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Absorbable chest scaffold aims to reshape sunken sternum without metal

NCT ID NCT05451108

Disease control Sponsor: BellaSeno Pty Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial tests a new approach for pectus excavatum, a condition where the chest appears sunken. The method uses a custom 3D-printed scaffold made of absorbable material, similar to dissolvable stitches, combined with the patient's own fat cells to fill and reshape the chest. The scaffold supports tissue growth and then dissolves over time, leaving natural tissue behind. The study involves 7 adults aged 18 to 55 and focuses on safety and how well the fat and scaffold integrate.

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 absorbable polycaprolactone scaffold with autologous fat grafting
What this could lead to
If it works, this could offer a less invasive way to correct pectus excavatum using the body's own healing, avoiding permanent metal implants.
What could go wrong
This is a very small early safety trial with only 7 participants, so results may not apply broadly. Risks include infection, poor fat retention, or scaffold-related complications.

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

7 people

The number who actually took part.

Started

Dec 2021

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 to 54 years

Sex

Anyone

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. Pectus excavatum defect 2. Patient aged ≥18 and \<55 years (patients 55 years and over may still be eligible pending assessment by investigating team and documentation of rationale) 3. Patient willing and able to comply with the study requirements. 4. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia). 5. Patient capable of providing valid informed consent. Exclusion Criteria: 1. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency. 2. Patient with 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 Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results. 3. Patient with unstable cardiac or respiratory function due to pectus excavatum or those requiring functional repair. 4. Patients with Body Mass Index (BMI) below 18.5 kg/m2 and above 30 kg/m2. NB: Patients with BMI up to 10% higher than the upper limit (up to 33 kg/m2) can be still enrolled if the treating surgeon confirms that BMI is not associated with any kind of pathology. 5. Patient with polycaprolactone (PCL) allergy 6. Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery. 7. Women of childbearing potential without an appropriate contraceptive method. 8. Patient with life expectancy \< 36 months.

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Conditions

The condition(s) this trial relates to.

pectus excavatum

As listed by the trial registrant

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

Pectus excavatum

Contacts and locations

Locations

  • Princess Alexandra Hospital - Wooloongabba

    Brisbane, Queensland, 4102, Australia

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