Clinical trial evaluating feasibility and safety of medical-grade polycaprolactone-PCL breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgery

BellaSeno Pty Ltd0 sites19 target enrollmentJanuary 28, 2022

Overview

No summary available.

Registry

who.int

Start Date

January 28, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

Female

Sponsor

•1\. Females over the age of 18 requiring pre\-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral.
•2\. Patient willing and able to comply with the study requirements.
•3\. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
•4\. Patient capable of providing valid informed consent.
•5\. Patient has sufficient body fat for homologous transplantation.
•; 1\. Females over the age of 18 requiring pre\-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral.
•2\. Patient willing and able to comply with the study requirements.
•3\. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
•4\. Patient capable of providing valid informed consent.
•5\. Patient has sufficient body fat for homologous transplantation.

•Patients may not participate in the clinical investigation if they meet ANY of the following criteria:
•1\. Patients who have undergone Radical Mastectomy or radical removal of chest wall soft tissue.
•2\. Patients who have had breast or chest wall irradiation.
•3\. Prior history of infection in the breast region in the preceding 12 months.
•4\. Patients diagnosed with or having a prior history of Breast Implant\-Associated Anaplastic Large Cell Lymphoma (BIA\-ALCL).
•5\. The patient has any condition or disease, including uncontrolled diabetes (e.g., HbA1c \> 8%), that is clinically known to impact wound healing ability.
•6\. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
•7\. 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.
•8\. 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).
•9\. Polycaprolactone (PCL) allergy