Breast revision with an absorbable PCL scaffold and your own fat grafts
Clinical Investigation Evaluating Medical Grade Polycaprolactone (PCL) Breast Scaffold Implantation in Conjunction With Autologous Fat Grafting for Breast Implant Revision Surgery
This trial will try an absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting to rebuild soft tissue for women having implant revision surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | BellaSeno GmbH Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Sydney, New South Wales and 5 other locations) |
| Trial ID | NCT07367698 on ClinicalTrials.gov |
What this trial studies
The procedure removes existing silicone implants if present, then implants an absorbable PCL scaffold together with autologous fat grafting to reconstruct soft tissue after implant revision. The PCL scaffold is a resorbable material with a long clinical history and is intended to support tissue while gradually being absorbed. Participants will undergo surgery at specialist centers and attend scheduled follow-up visits including imaging such as MRI to monitor safety and clinical performance. This study follows a successful two‑year safety and feasibility evaluation performed at the Royal Brisbane and Women's Hospital.
Who should consider this trial
Good fit: Ideal candidates are genetically female adults (18+) undergoing bilateral cosmetic breast implant revision whose target volume fits available scaffold sizes and who are eligible for MRI and willing to maintain stable weight and avoid elective breast surgery for three years.
Not a fit: Patients who lack sufficient donor fat or harvest sites, are ineligible for MRI, or cannot commit to weight stability or the three‑year restriction on further breast procedures may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, the technique could restore breast shape and volume using a resorbable scaffold plus the patient’s own fat, potentially avoiding replacement implants and lowering long‑term implant‑related problems.
How similar studies have performed: A preceding two‑year safety and feasibility evaluation at the Royal Brisbane and Women's Hospital (NCT05437757) was completed successfully, supporting this larger performance and safety study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria To be eligible to participate in this clinical investigation, patients must meet ALL of the following criteria: 1. Genetically female 2. Patients, age from 18 years old undergoing surgical revision of bilateral breast implants originally placed for cosmetic augmentation 3. Patients with a target volume that can be treated with the available catalogue of PCL scaffold sizes 4. Eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia) 5. Agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study 6. Agree to not undergo any elective cosmetic surgery on her breasts for a minimum of 3 years following implantation of the investigational device Exclusion Criteria Patients may not participate in the clinical investigation if they meet ANY of the following criteria: 1. Based on the judgement of the Investigator, inadequate sites/ volume for harvesting the fat graft 2. Medical history of any malignant condition in the breast or chest wall region 3. Medical history of BRCA 1 or BRCA 2 Mutation 4. Abnormal findings on diagnostic imaging in the breast(s) intended for treatment within one year of study enrolment 5. Prior history of infection in the breast in the preceding 12 months 6. Prior surgery involving the breast in the preceding 12 months (except any previous removal of silicone implant) 7. Breast feeding in the preceding 12 months 8. Any local infection or rash within or close to the surgical fields (harvest site(s) or breasts) 9. Medical history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC) 10. The patient has any disease, that is clinically known to impact wound healing ability 11. Known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency 12. Micro or macro angiopathia 13. Uncontrolled endocrine disorders 14. Clotting disorders, including thromboembolism 15. 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 16. Polycaprolactone (PCL) allergy 17. Currently pregnant or breast feeding, or who are planning to become pregnant within 5 years after the breast surgery 18. 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) 19. 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) 20. Known allergies to MRI contrast agents 21. Unable or unwilling to comply with the treatment protocol 22. Unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment 23. Currently enrolled or has plans to enrol in another clinical study that would interfere with this study, unless it is retrospective or observational 24. 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
Where this trial is running
Sydney, New South Wales and 5 other locations
- Macquarie University Hospital — Sydney, New South Wales, Australia (Recruiting)
- Westmead Hospital, Lakeview Private Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
- Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI) — Brisbane, Queensland, Australia (Not_yet_recruiting)
- Zealand University Hospital — Roskilde, Region Sjælland, Denmark (Not_yet_recruiting)
- Evangelisches Krankenhaus Göttingen-Weende — Göttingen, Lower Saxony, Germany (Not_yet_recruiting)
- Universitätsklinikum Münster — Münster, North Rhine-Westphalia, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Professor Owen Ung — Royal Brisbane and Women's Hospital, Herston Biofabrication Institute
- Study coordinator: Professor Owen Ung
- Email: owen.ung@health.qld.gov.au
- Phone: +61 736460177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.