Breast Implant Revision Clinical Trial
Official title:
Clinical Trial Evaluating Medical-grade Polycaprolactone-PCL Breast Scaffold Implantation With Autologous Fat Grafting for Breast Implant Revision and Congenital Defect Correction Surgery
Verified date | June 2024 |
Source | BellaSeno GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 frame to support this growth of cells. The scaffold will be resorbed within at least 3 years. The main assumption of this clinical trial is that the method used is safe and effective for treatment of women requiring a silicone implant and /or correction of breast defect and/or deformity. The other assumption is that this method is applicable to a wider range of tissue defects, such as breast reconstruction after breast tissue removal. The new method is called '3D printed scaffold-based soft tissue regeneration', and uses a combination of own fat cells (called adipocytes) with a 3D printed scaffold to support soft tissue regeneration using the natural healing processes in their body. This substance is resorbable and is similar to the substance used for sutures and stitches that are dissolvable or resorbable in the body. The substance used for the scaffold is already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the their own tissue in its place. The combination of scaffold implantation and their own fat cells is the novel method in this trial. Conventional liposuction techniques are used from another site on the patients body to harvest their fat cells.
Status | Active, not recruiting |
Enrollment | 19 |
Est. completion date | December 17, 2025 |
Est. primary completion date | December 17, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Brisbane and Women's Hospital (RBWH) | Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
BellaSeno Pty Ltd |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative device safety | Feasibility assessed through post-operative device safety measured through the adverse device effect rate (ADE rate). Adverse events are defined as per EN ISO 14155:2020. This will be regularly monitored during impatient and outpatient follow up. | Assessed daily during inpatient stay at 1-week, 2-,6-,12- and 24-months post-surgery. | |
Secondary | Adverse Event rate and severity | Adverse events and severity are defined as per EN ISO 14155:2020. Regularly monitored during inpatient and outpatient follow up. | Assessed daily during inpatient stay at 1-week, 2-,6-,12- and 24-months post-surgery. | |
Secondary | Frequency of complication | Composite outcome of short term and long term complications. This will be regularly monitored during inpatient and outpatient follow up with a study-specific questionnaire. | Short term complications will be assessed at 1-week and 2-months follow-up visits.Long term complications will be assessed at 6-months, 12-months and 24-months follow-up visits. | |
Secondary | Number of revision surgeries due to Adverse Device Effects | Adverse events are defined as per EN ISO 14155:2020. This will be regularly monitored during inpatient and outpatient follow up with a study-specific questionnaire. | Assessed daily during inpatient stay, at 1-week, 2-,6-,12- and 24-months post-surgery. | |
Secondary | Feasibility assessed through frequency of successful breast surgeries | This will be assessed as a composite outcome of:
Number of successful surgeries, Clinical images (photographs, 3D scan, 180° video). |
The frequency of successful breast surgeries will be assessed at the 24-month visit. The outcome of the surgeries will be assessed at enrolment and at 1-week, 2-, 6-, 12- and 24-month post-surgery. | |
Secondary | Feasibility assessed through patient reported breast-specific outcomes | It will be measured using the BREAST-Q questionnaire.
Scales: Quality of Life: Physical Well-Being: Chest Psychosocial Well-Being Sexual Well-Being Satisfaction: Breasts |
Assessed at 2-,6-,12- and 24-months post-surgery. | |
Secondary | Feasibility assessed through volume replacement | This will be assessed as a composite outcome of:
Sternal notch to nipple (SN-N) measured in millimetres with tape measure and calipers Breast Base Width (BBW) measured in millimetres with tape measure and calipers Breast Height measured in millimetres with tape measure and calipers Nipple to IMF-(N-IMF) measured in millimetres with tape measure and calipers MRI (breast volume, scaffold volume and fat volume within scaffold measured in cc) MRI with contrast (only at 24-month post-surgery) |
Assessed at enrolment and at 2-, 6-, 12- and 24-month post-surgery. |
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