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ACTIVE NOT RECRUITING
NCT05451108
NA

Pectus Excavatum Camouflage

Sponsor: BellaSeno Pty Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: A Clinical Trial Evaluating Medical-Grade Polycaprolactone-PCL Pectus Scaffold Implantation With Autologous Fat Grafting for Pectus Excavatum Camouflage

Key Details

Gender

All

Age Range

18 Years - 54 Years

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2021-12-14

Completion Date

2026-01

Last Updated

2025-02-07

Healthy Volunteers

No

Interventions

DEVICE

PCL Pectus Scaffold implantation and autologous fat grafting

A small incision is made in the chest and pre-sternal pocked is defined. Following this, an empty scaffold is implanted at the site of the defect with skin closed directly over it. At the same stage, autologous fat transfer will be performed, harvesting fat from available donor sites such as the thighs and abdomen - depending on scaffold volume and patient morphology. The area will be infiltrated with local anaesthetic tumescent fluid, liposuction performed, and fat transferred to syringes for filtration prior to injection into the scaffold. Fat will not be processed beyond simple filtration to separate liquid from fat to be injected. The scaffold provides structural stability to the chest during the infiltration of the tissue inside the scaffold.

Locations (1)

Princess Alexandra Hospital - Wooloongabba

Brisbane, Queensland, Australia