Clinical trial evaluating feasibility and safety of medical-grade polycaprolactone-PCL Pectus scaffold implantation with autologous fat grafting for pectus excavatum camouflage

BellaSeno Pty Ltd0 sites7 target enrollmentJune 24, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 24, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•oPectus excavatum defect
•oPatient aged \>18 and \<55 years, inclusive, (patients 55 years and over may still be eligible pending assessment by investigating team and documentation of rationale)
•oPatient willing and able to comply with the study requirements.
•oPatient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
•oPatient capable of providing valid informed consent.

•oPatient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
•oPatient 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.
•oPatient with unstable cardiac or respiratory function due to pectus excavatum or those requiring functional repair.
•oPatients 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.
•oPatient with Polycaprolactone (PCL) allergy
•oWomen who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery.
•oWomen of childbearing potential without an appropriate contraceptive method.
•oPatient life expectancy \< 36 months.