The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction". The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the patient's chest using the body's natural healing processes.
The implanted scaffold acts as a resorbable frame to support the growth of cells. The substance used for the scaffold is resorbable, it's similar to the substance used for sutures and stitches, and it's already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the tissue in its place.
Who can participate
Age range
18 Years – 54 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pectus excavatum defect
. Patient aged ≥18 and \<55 years (patients 55 years and over may still be eligible pending assessment by investigating team and documentation of rationale)
. Patient willing and able to comply with the study requirements.
. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
. Patient capable of providing valid informed consent.
Exclusion criteria
. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of occurrence and type of SADE and AEs related to the surgical procedure or the device (e.g. vital signs, physical exam findings and cardiorespiratory function from baseline to end of study visit) to ensure the safety of device and procedure.
Timeframe: Assessed daily during inpatient stay and at 1-week, at 1-,3-,6-,12-, 24-months and any relevant unscheduled visits post-surgery with 2 years post-surgery being the primary time-point.
. 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.
. Patient with unstable cardiac or respiratory function due to pectus excavatum or those requiring functional repair.
. 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.
. Patient with polycaprolactone (PCL) allergy
. Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery.
. Women of childbearing potential without an appropriate contraceptive method.