Scaffold-guided Breast Implant Revision Surgery

NCT07367698 | Recruiting DMC

• 1 other identifier: 2025-BRV-005
• Study Type: interventional
• Target: 73
• Locations: 3 countries
• Sites: 6

Brief Summary

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

Breast Augmentation Complications; Breast Implant Revision

Keywords

Breast scaffold; PCL Scaffold; Absorbable Implant; Regenerative Medicine; Implant Removal; Breast Surgery; Clinical Safety and Performance

Outcome Measures

Primary Outcomes (1)

• Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs aftersurgical revision of permanent breast implants 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

Secondary Outcomes (6)

• Breast revision surgery rate

  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

  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)

  Assessed at enrolment 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)

  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

  Assessed at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery

Study Arms (1)

Implantation of the PCL Breast scaffold with autologous fat grafting

EXPERIMENTAL

Implantation of the PCL Breast Scaffold with autologous fat graft for breast augmentation implant revision

Device: Implantation of the PCL Breast scaffold with autologous fat grafting

Interventions

Implantation of the PCL Breast scaffold with autologous fat grafting DEVICE

The PCL Breast Scaffold is implanted either immediately following the removal of a silicone implant or during a delayed procedure. The surgery uses the same surgical pocket from the previous augmentation for insertion of the PCL Breast Scaffold, or, if implants have been previously removed, a new surgical pocket will be created. The PI will ensure accurate placement and secure fixation of the scaffold in the desired anatomical position. Autologous fat grafting (AFG) is then performed: the fat cells are harvested from the abdomen and/or thighs and injected into the implanted scaffold at the time of initial implantation. Lastly, after the AFG has been performed, 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. In conjunction with scaffold implantation, concurrent breast procedures may be performed on a case-by-case basis (e.g., Mastopexy,...).

Implantation of the PCL Breast scaffold with autologous fat grafting

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this clinical investigation, patients must meet ALL of the following criteria:
• Genetically female
• Patients, age from 18 years old undergoing surgical revision of bilateral breast implants originally placed for cosmetic augmentation
• 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

You may not qualify 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
• Prior surgery involving the breast in the preceding 12 months (except any previous removal of silicone implant)
• 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

Sponsors & Collaborators

• BellaSeno Pty Ltd: lead

Study Sites (6)

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

RECRUITING

Westmead Hospital, Lakeview Private Hospital

Sydney, New South Wales, 2145, Australia

NOT YET RECRUITING

Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)

Brisbane, Queensland, 4029, Australia

NOT YET RECRUITING

Zealand University Hospital

Roskilde, Region Sjælland, 4000 Roskilde, Denmark

NOT YET RECRUITING

Evangelisches Krankenhaus Göttingen-Weende

Göttingen, Lower Saxony, 37075 Göttingen, Germany

NOT YET RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149 Münster, Germany

NOT YET RECRUITING

Study Officials

• Professor Owen Ung

  Royal Brisbane and Women's Hospital, Herston Biofabrication Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Owen Ung

CONTACT

+61 736460177; owen.ung@health.qld.gov.au

Professor Anand Deva

CONTACT

+61(2) 95252340; anand.deva@ishc.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); DK (1); AU (3)