Scaffold-guided Breast Implant Revision Surgery

March 4, 2026 updated by: BellaSeno Pty Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University Hospital
        • Contact:
        • Principal Investigator:
          • Professor Anand Deva
      • Sydney, New South Wales, Australia, 2145
        • Not yet recruiting
        • Westmead Hospital, Lakeview Private Hospital
        • Contact:
        • Principal Investigator:
          • A/Professor James French
        • Sub-Investigator:
          • Professor Elisabeth Elder
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Not yet recruiting
        • Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
        • Contact:
        • Principal Investigator:
          • Professor Owen Ung
        • Sub-Investigator:
          • Professor Karin Steinke
  • Denmark
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4000 Roskilde
        • Not yet recruiting
        • Zealand University Hospital
        • Contact:
        • Principal Investigator:
          • Professor Nicco Krezdorn
  • Germany
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075 Göttingen
        • Not yet recruiting
        • Evangelisches Krankenhaus Göttingen-Weende
        • Contact:
        • Principal Investigator:
          • Doctor Tobias Mett
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149 Münster
        • Not yet recruiting
        • Universitatsklinikum Munster
        • Contact:
        • Principal Investigator:
          • Professor Maximilian Kückelhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Implantation of the PCL Breast scaffold with autologous fat grafting
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

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,...).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs aftersurgical revision of permanent breast implants 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
Assessed at post-surgery, at 1 week and at 3-, 6- and 12-month post sugery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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)
Time Frame: Assessed at enrolment and at 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-surgery

Total breast volume primarily assessed through 3D imaging. 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
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)
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. Results are reported as a transformed score range from 0 to 100, with higher scores reflecting a better outcome.
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
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.
Assessed at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery
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.
Assessed at surgery and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BellaSeno Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Professor Owen Ung, Royal Brisbane and Women's Hospital, Herston Biofabrication Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-BRV-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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