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Clinical Trial

Pectus Excavatum Camouflage (IT)

NCT: NCT05634070 · ACTIVE_NOT_RECRUITING

NCT IDNCT05634070
StatusACTIVE_NOT_RECRUITING
Start Date2022-12-28
SponsorBellaSeno GmbH (INDUSTRY)
First posted
Last updated

Brief Summary

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 absorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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