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The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation and breast augmentation revision surgery following previous breast implant insertion. The material (PCL) has been in clinical use for many decades and is absorbable. This study follows the successful completion of a 2-year evaluation of the safety and feasibility of this technique performed by the Royal Brisbane and Women's Hospital (ClinicalTrials.gov ID: NCT05437757).
The main question it aims to answer is: "Is PCL Breast Scaffold with autologous fat graft a safe and effective method for soft tissue reconstruction following breast implant revision and for primary breast augmentation?".
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation of the PCL Breast scaffold with autologous fat grafting | Experimental | Implantation of the PCL Breast Scaffold with autologous fat graft for breast implant revision or for primary breast augmentation surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of the PCL Breast scaffold with autologous fat grafting | Device | The PCL Breast Scaffold is implanted in a pre-pectoral pocket immediately following removal of the silicone breast implant in participants undergoing breast implant revision. For participants whose implants have been previously removed, or those undergoing primary breast augmentation, a pre-pectoral pocket is created. The use of a submuscular placement may be allowed at discretion of the PI. In conjunction with scaffold implantation, concurrent breast procedures may be performed on a case-by-case basis (e.g., Mastopexy,...). The PI will ensure accurate placement and secure fixation of the scaffold in the desired anatomical position. Autologous fat grafting (AFG) is then performed using fat cells harvested from the abdomen and/or thighs and injected into the implanted scaffold at the time of initial implantation. Then, wound closure and dressing will be conducted as per standard procedure. Sterile bandaging shall be initially applied and the wound reviewed daily whilst an inpatient. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs after index surgery within 12 months | Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time | Assessed at post-surgery, at 1 week and at 3-, 6- and 12-month post sugery |
| Measure | Description | Time Frame |
|---|---|---|
| Breast revision surgery rate | Number of breast revision surgeries categorized by reason and time | Assessed at post-surgery and at 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery |
| Rate and severity of all AEs related to device and/or procedure |
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Inclusion Criteria
To be eligible to participate in this clinical investigation, patients must meet ALL of the following criteria:
Genetically female
Patients with a target volume that can be treated with the available catalogue of PCL scaffold sizes
Eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia)
Agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study
Agree to not undergo any elective cosmetic surgery on her breasts for a minimum of 3 years following implantation of the investigational device
Additional inclusion criteria applicable to the Revision Augmentation Cohort
Patients, age from 18 years old undergoing surgical revision of breast implants originally placed for cosmetic augmentation
Additional inclusion criteria applicable to the Primary Augmentation Cohort:
6. Patients, age from 18 years old undergoing primary augmentation surgery
Exclusion Criteria
Patients may not participate in the clinical investigation if they meet ANY of the following criteria:
Based on the judgement of the Investigator, inadequate sites/ volume for harvesting the fat graft
Medical history of any malignant condition in the breast or chest wall region
Medical history of BRCA 1 or BRCA 2 Mutation
Abnormal findings on diagnostic imaging in the breast(s) intended for treatment within one year of study enrolment
Prior history of infection in the breast in the preceding 12 months
Prior surgery involving the breast in the preceding 12 months (except any previous removal of silicone implant) including autologous fat grafting.
Breast feeding in the preceding 12 months
Any local infection or rash within or close to the surgical fields (harvest site(s) or breasts)
Medical history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
The patient has any disease, that is clinically known to impact wound healing ability
Known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency
Micro or macro angiopathia
Uncontrolled endocrine disorders
Clotting disorders, including thromboembolism
Known severe concurrent or intercurrent illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Investigator, compromise safety or compliance, or interfere with interpretation of study results
Polycaprolactone (PCL) allergy
Currently pregnant or breast feeding, or who are planning to become pregnant within 5 years after the breast surgery
Actively smoking or have a history of smoking (patient with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)
Actively using recreational drugs or have a history of use of recreational drugs (patients with a history of use of recreational drugs may still be eligible pending assessment by investigating team and documentation of rationale)
Known allergies to MRI contrast agents
Unable or unwilling to comply with the treatment protocol
Unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment
Currently enrolled or has plans to enrol in another clinical study that would interfere with this study, unless it is retrospective or observational
Any patient condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes, or would preclude participation in the study
Additional exclusion criteria applicable solely to the Primary Augmentation Cohort:
Any prior surgery in one or both breasts that in the opinion of the PI could compromise the study
Females
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor Owen Ung | Contact | +61 736460177 | owen.ung@health.qld.gov.au | |
| Professor Anand Deva | Contact | +61(2) 95252340 | anand.deva@ishc.org.au |
| Name | Affiliation | Role |
|---|---|---|
| Professor Owen Ung | Royal Brisbane and Women's Hospital, Herston Biofabrication Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University Hospital | Recruiting | Sydney | New South Wales | 2109 | Australia |
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This is a single-arm study. Participants are enrolled into two predefined cohorts:
All participants receive the same investigational device. The sample size is of 87 participants: 34 in the Revision Augmentation Cohort and 53 in the Primary Augmentation Cohort
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|
Number of AEs categorised by relationship with device and/or procedure (possible, probable, causal), severity and type over time |
| Assessed at post-surgery, 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery |
| Total breast volume retention (3D Imaging) | Total breast volume primarily assessed through 3D imaging. In case of immediate replacement, wight of the removed tissue and size of the removed silicone implant is also considered for total breast volume. Supportive data generated by:
| Assessed at enrolment, surgery, and at 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-surgery |
| Assessment of patient satisfaction, quality of life, body image, and psychological well-being using validated questionnaires (BREAST-Q) | Patient-reported outcomes will be measured using the validated BREAST-Q questionnaire. The BREAST-Q Reconstruction module will be administered to participants of the Revision Augmentation Cohort, while the BREAST-Q Augmentation module will be administered to participants of the Primary Augmentation Cohort. Results are reported as a transformed score range from 0 to 100, with higher scores reflecting a better outcome. | Assessed at enrolment and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery |
| Assessment of patient satisfaction, quality of life, body image, and psychological well-being using a 5-point Likert scale questionnaire | Patient-reported outcomes will be measured through a 5-point Likert scale questionnaire. Scores range from 1 to 5, with higher scores indicating better outcomes. | Assessed at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery |
| Assessment of surgical usability and surgeon satisfaction using a 5-point Likert scale questionnaire | The 5-point Likert scale questionnaire is administered to the PIs performing the surgical procedure. Scores range from 1 to 5, with higher scores indicating a better usability and greater surgeon satisfaction. | Assessed at surgery and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery |
| Westmead Hospital, Lakeview Private Hospital | Not yet recruiting | Sydney | New South Wales | 2145 | Australia |
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| Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI) | Not yet recruiting | Brisbane | Queensland | 4029 | Australia |
|