Status:
ACTIVE_NOT_RECRUITING
Scaffold-guided Breast Surgery
Lead Sponsor:
BellaSeno Pty Ltd
Conditions:
Breast Implant Revision
Congenital Breast Defect Correction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a resorbable fra...
Detailed Description
A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted for breast revision an/or congenital defect correction. First the patient will be thoroughly evaluated with hist...
Eligibility Criteria
Inclusion
- Females over the age of 18 requiring pre-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral.
- Patient willing and able to comply with the study requirements.
- Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
- Patient capable of providing valid informed consent.
- Patient has sufficient body fat for homologous transplantation.
Exclusion
- Patients who have undergone Radical Mastectomy or radical removal of chest wall soft tissue.
- Patients who have had breast or chest wall irradiation.
- Prior history of infection in the breast region in the preceding 12 months.
- Patients diagnosed with or having a prior history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
- The patient has any condition or disease, including uncontrolled diabetes (e.g., HbA1c \> 8%), that is clinically known to impact wound healing ability.
- Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
- 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.
- 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).
- Polycaprolactone (PCL) allergy
- Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the breast surgery.
- Patient ineligible to undergo MRI.
- Patient unable or unwilling to comply with the treatment protocol.
- Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
- Patients with a history of smoking (patients with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05437757
Start Date
June 15 2022
End Date
December 17 2025
Last Update
July 4 2025
Active Locations (1)
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1
Royal Brisbane and Women's Hospital (RBWH)
Brisbane, Queensland, Australia, QLD 4029