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New treatment option for Breast Implant Revision
Official title Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
ClinicalTrials.gov ID: NCT07367698
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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 applicable to the Revision Augmentation Cohort
- Patients, age from 18 years old undergoing surgical revision of breast implants originally placed for cosmetic augmentation Additional applicable to the Primary Augmentation Cohort: 6\. Patients, age from 18 years old...
What rules you out
- 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...
- 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...
- 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...
- Any prior surgery in one or both breasts that in the opinion of the PI could compromise the study
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Brisbane, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.