Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT05437757
Eligibility Criteria:
Inclusion Criteria:
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.
Exclusion 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
10. Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the breast surgery.
11. Patient ineligible to undergo MRI.
12. Patient unable or unwilling to comply with the treatment protocol.
13. Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
14. 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05437757
Study Brief:
Protocol Section:
NCT05437757