Actively Recruiting
Scaffold-guided Breast Implant Revision Surgery
Led by BellaSeno Pty Ltd · Updated on 2026-03-05
73
Participants Needed
6
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this clinical trial is to generate robust data that demonstrates clinical performance and safety of a polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) in women who seek a revision surgery of a breast implant used for breast augmentation. 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 of soft tissue reconstruction following breast implant revision?". Participants will: * Undergo removal of their existing silicone breast implant (if not previously removed), * Receive implantation of a PCL Breast Scaffold combined with autologous fat grafting (AFG), and * Attend follow-up visits at 1 week, 3 months, 6 months, and annually for up to 5 years for clinical assessments and questionnaires.
CONDITIONS
Official Title
Scaffold-guided Breast Implant Revision Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetically female
- Age 18 years or older undergoing surgical revision of bilateral breast implants originally placed for cosmetic augmentation
- Target breast volume treatable with available PCL scaffold sizes
- Eligible to undergo MRI (no incompatible metal devices or severe claustrophobia)
- Agree to maintain weight within 5% during the study
- Agree not to have elective cosmetic breast surgery for at least 3 years after scaffold implantation
You will not qualify if you...
- Inadequate fat graft volume or sites as judged by Investigator
- History of malignant breast or chest wall conditions
- Known BRCA 1 or BRCA 2 gene mutation
- Abnormal breast imaging findings within 1 year before enrollment
- Breast infection in the past 12 months
- Breast surgery in the past 12 months (except implant removal)
- Breastfeeding in the past 12 months
- Local infection or rash near surgical sites
- History of Breast Implant-Associated Anaplastic Large Cell Lymphoma or Squamous Cell Carcinoma
- Diseases affecting wound healing
- Known immunodeficiency or related treatments
- Micro or macro angiopathia
- Uncontrolled endocrine disorders
- Clotting disorders including thromboembolism
- Severe concurrent illnesses or psychiatric disorders affecting safety or compliance
- Allergy to polycaprolactone (PCL)
- Currently pregnant, breastfeeding, or planning pregnancy within 5 years
- Active or history of smoking without documented assessment
- Active or history of recreational drug use without documented assessment
- Allergy to MRI contrast agents
- Unable or unwilling to follow treatment protocol or provide informed consent
- Enrolled or planning enrollment in interfering clinical studies
- Any condition precluding device use or study participation as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Macquarie University Hospital
Sydney, New South Wales, Australia, 2109
Actively Recruiting
2
Westmead Hospital, Lakeview Private Hospital
Sydney, New South Wales, Australia, 2145
Not Yet Recruiting
3
Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
Brisbane, Queensland, Australia, 4029
Not Yet Recruiting
4
Zealand University Hospital
Roskilde, Region Sjælland, Denmark, 4000 Roskilde
Not Yet Recruiting
5
Evangelisches Krankenhaus Göttingen-Weende
Göttingen, Lower Saxony, Germany, 37075 Göttingen
Not Yet Recruiting
6
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149 Münster
Not Yet Recruiting
Research Team
P
Professor Owen Ung
CONTACT
P
Professor Anand Deva
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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