Study
Recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Macquarie University Hospital | Sydney | NSW | Recruiting |
| Westmead Hospital, Lakeview Private Hospital | Sydney | NSW | Not yet recruiting |
| Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI) | Brisbane | QLD | Not yet recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria
To be eligible to participate in this clinical investigation, patients must meet ALL of the following criteria:
1. Genetically female
2. Patients with a target volume that can be treated with the available catalogue of PCL scaffold sizes
3. Eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia)
4. Agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study
5. 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
6. 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:
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) including autologous fat grafting.
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
Additional exclusion criteria applicable solely to the Primary Augmentation Cohort:
25. Any prior surgery in one or both breasts that in the opinion of the PI could compromise the study
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 10 July 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.