A dissolving scaffold may help camouflage a sunken chest
NCT ID NCT05634070
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial tests whether a custom-made, absorbable polycaprolactone (PCL) scaffold, combined with the patient's own fat, can safely improve the appearance of pectus excavatum (a sunken chest) in people who cannot have standard corrective surgery. The scaffold is designed to support new tissue growth and then dissolve over time, potentially avoiding long-term implant complications. The study will monitor safety, fat retention, pain, wound healing, and quality of life in 10 participants over about one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a custom-made absorbable polycaprolactone (PCL) scaffold implanted under the skin, combined with the patient's own fat grafting
- What this could lead to
- If successful, this approach could offer a less invasive, absorbable option to improve chest appearance in people with pectus excavatum who are not candidates for conventional surgery.
- What could go wrong
- This is a very small early-stage trial with only 10 participants, so results may not apply widely. Risks include infection, poor fat retention, scaffold displacement, or the need for additional procedures.
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
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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14 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Genetic female patients of age 14 years and up OR Genetic male patients of age 16 years and up without cardiopulmonary compromise seeking correction or improvement of pectus excavatum-associated with anterior chest wall deformity and/or congenital defect. 2. Patient willing and able to comply with the study requirements (e.g., all scheduled appointments). 3. Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia). 4. Patient and his/her parents/legal guardian (in case of minor patients) capable of providing valid written informed consent. 5. Have sufficient body fat for homologous transplantation. 6. The patient/Guardian has "realistic" expectations of surgical results as determined by the PI. Exclusion Criteria: 1. Genetic females less than 14 years of age at the time of surgery. 2. Genetic males less than 16 years of age at the time of surgery. 3. Active infection anywhere in the body. 4. Patient chest wall tissue is clinically incompatible for the procedure as determined by PI. 5. Compromised vascularity in the pectoralis muscle and subcutaneous tissue. 6. Patient and is/her parents/legal guardian (in case of minor patients) unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment. 7. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy, or other cause for secondary/primary immunodeficiency. 8. 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. 9. Patient with unstable cardiac or respiratory function due to pectus excavatum or those still requiring functional repair. 10. 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). 11. Female patients who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery. 12. Female patients of childbearing potential without an appropriate contraceptive method. 13. Patient ineligible to undergo MRI. 14. Patient life expectancy \< 36 months. 15. Patient unable or unwilling to comply with the treatment protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Meyer Children's Univeristy Hospital
Florence, Italy, 50139, Italy
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