The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT). The study aims to demonstrate the safety and clinical performance of the insertion of an absorbable "medical-grade polycaprolactone-PCL Pectus Scaffold" in the thorax region with Autologous Fat Grafting in the correction of congenital Pectus Excavatum unsuitable for conventional treatment with stable cardio-respiratory function. The PCL Pectus Scaffold-based design has the potential to induce sustained regeneration to fill large volume pectus excavatum defects, with the added benefit of being light weight and resorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.
Age range
14 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Rate of adverse events and serious adverse events from the time of surgery to the end of study visit.
Timeframe: Assessed at 24 post-surgery months
Change in (fat) volume % and soft tissue retention % within the scaffold (radiological and/or clinical) from the time of surgery to the end of study visit using radiological and clinical assessments
Timeframe: Assessed at 1-,6-,12-,24-months post-surgery
Preservation of pre-operative functional status
Timeframe: Assessed at 12-months post-surgery
Change in pain assessments from baseline to the end of study visit
Timeframe: Assessed at 1-month post surgery
Change in wound healing from the time of surgery to the end of study visit
Timeframe: Assessed at 1-month post surgery
Change in patient quality of life as assessed by Quality of Life (QoL) questionnaires from baseline to the end of study visit
Timeframe: Assessed at 3, 6, 12 and 24 month - clinical review