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NCT Number: NCT07367698

Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery

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. 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 for soft tissue reconstruction following breast implant revision and for primary breast augmentation?".

Participants will:

* Undergo removal of their existing silicone breast implant (only for participants undergoing breast implant revision, if the implant has not been 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.

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Key information

Conditions

Breast Implant Revision Breast Augmentation Complications Primary Breast Augmentation Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Macquarie University Hospital, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 inclusion criteria applicable to the Revision Augmentation Cohort

  • 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:

  • 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:

  • 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 Investigator, compromise safety or compliance, or interfere with interpretation of study results
  • 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 rationale)
  • 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

Additional exclusion criteria applicable solely to the Primary Augmentation Cohort:

  • Any prior surgery in one or both breasts that in the opinion of the PI could compromise the study

Treatment and study plan

Implantation of the PCL Breast scaffold with autologous fat grafting

Device

The PCL Breast Scaffold is implanted in a pre-pectoral pocket immediately following removal of the silicone breast implant in participants undergoing breast implant revision. For participants whose implants have been previously removed, or those undergoing primary breast augmentation, a pre-pectoral pocket is created. The use of a submuscular placement may be allowed at discretion of the PI. In conjunction with scaffold implantation, concurrent breast procedures may be performed on a case-by-case basis (e.g., Mastopexy,...). The PI will ensure accurate placement and secure fixation of the scaffold in the desired anatomical position. Autologous fat grafting (AFG) is then performed using fat cells harvested from the abdomen and/or thighs and injected into the implanted scaffold at the time of initial implantation. Then, 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.

Primary outcomes

  1. Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs after index surgery within 12 months

    Time frame: Assessed at post-surgery, at 1 week and at 3-, 6- and 12-month post sugery

    Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time

Secondary outcomes

  1. Breast revision surgery rate

    Time frame: 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

    Number of breast revision surgeries categorized by reason and time

  2. Rate and severity of all AEs related to device and/or procedure

    Time frame: Assessed at post-surgery, 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery

    Number of AEs categorised by relationship with device and/or procedure (possible, probable, causal), severity and type over time

  3. Total breast volume retention (3D Imaging)

    Time frame: Assessed at enrolment, surgery, and at 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-surgery

    Total breast volume primarily assessed through 3D imaging. In case of immediate replacement, wight of the removed tissue and size of the removed silicone implant is also considered for total breast volume. Supportive data generated by:

    • Dynamic contrast enhanced Magnetic Resonance Imaging (DCE-MRI);
    • Breast anthropomorphic measurements taken with tape measure or with Vectra imaging system (Sternal notch to nipple (SN-N), Nipple to Inframammary Fold (N-IMF), Overbust measurement, Underbust measurement, Chest circumference at highest projection);
    • Digital photos

  4. Assessment of patient satisfaction, quality of life, body image, and psychological well-being using validated questionnaires (BREAST-Q)

    Time frame: Assessed at enrolment and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery

    Patient-reported outcomes will be measured using the validated BREAST-Q questionnaire. The BREAST-Q Reconstruction module will be administered to participants of the Revision Augmentation Cohort, while the BREAST-Q Augmentation module will be administered to participants of the Primary Augmentation Cohort. Results are reported as a transformed score range from 0 to 100, with higher scores reflecting a better outcome.

  5. Assessment of patient satisfaction, quality of life, body image, and psychological well-being using a 5-point Likert scale questionnaire

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

    Patient-reported outcomes will be measured through a 5-point Likert scale questionnaire. Scores range from 1 to 5, with higher scores indicating better outcomes.

  6. Assessment of surgical usability and surgeon satisfaction using a 5-point Likert scale questionnaire

    Time frame: Assessed at surgery and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery

    The 5-point Likert scale questionnaire is administered to the PIs performing the surgical procedure. Scores range from 1 to 5, with higher scores indicating a better usability and greater surgeon satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Anand Deva

CONTACT

[email protected]

+61(2) 95252340

Professor Owen Ung

CONTACT

[email protected]

+61 736460177

Sponsors and collaborators

Lead sponsor

BellaSeno Pty Ltd

Industry

Registry information

Official study title

Clinical Investigation Evaluating Medical Grade Polycaprolactone (PCL) Breast Scaffold Implantation in Conjunction With Autologous Fat Grafting for Breast Implant Revision and Primary Breast Augmentation Surgery

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jan 26, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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