Breast Implant RevisionNCT07367698
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
A study testing Implantation of the PCL Breast scaffold with autologous fat grafting in people with Breast Implant Revision and Breast Augmentation Complications, run by BellaSeno Pty Ltd at 3 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- What is being tested?
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 3 sitesAustralia
- Study dates
- 13 Feb 2026to Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- 6. Patients, age from 18 years old undergoing primary augmentation surgery
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Not yet recruiting
Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
Brisbane, Queensland, 4029
Owen Ung Professor, +61 736460177, owen.ung@health.qld.gov.au
Professor Owen Ung
- Recruiting
Macquarie University Hospital
Sydney, New South Wales, 2109
Professor Anand Deva, +61 295252340, anand.deva@ishc.org.au
Professor Anand Deva
- Not yet recruiting
Westmead Hospital, Lakeview Private Hospital
Sydney, New South Wales, 2145
A/Professor James French, +61 28850 8252, drjamesfrench@gmail.com
A/Professor James French
About this study
Official 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
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?".
Read more
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.
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Being tested
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Keywords
- Breast scaffold, PCL Scaffold, Absorbable Implant, Regenerative Medicine, Implant Removal, Breast Surgery, Clinical Safety and Performance, Primary Breast Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the PCL Breast scaffold with autologous fat graftingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Implantation of the PCL Breast scaffold with autologous fat grafting | Experimental | Implantation of the PCL Breast Scaffold with autologous fat graft for breast implant revision or for primary breast augmentation surgery Receives: Device: Implantation of the PCL Breast scaffold with autologous fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs after index surgery 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
Measured: Assessed at post-surgery, at 1 week and at 3-, 6- and 12-month post sugery
Secondary outcomes (6)
Breast revision surgery rate
Number of breast revision surgeries categorized by reason and time
Measured: 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
Number of AEs categorised by relationship with device and/or procedure (possible, probable, causal), severity and type over time
Measured: 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)
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
Measured: Assessed at enrolment, surgery, 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed at surgery and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start13 Feb 2026
- Primary completionJan 2032 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant RevisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm study. Participants are enrolled into two predefined cohorts: * Revision Augmentation Cohort: Women that previously received breast augmentation using a breast implant(s) and require breast implant augmentation revision surgery or have received breast implant explantation without replacement, meet the eligibility criteria and provide informed consent to participate in this study. * Primary Augmentation Cohort: Women undergoing their first breast procedure (no previous breast implants), meet the eligibility criteria and provide informed consent to participate in this study. All participants receive the same investigational device. The sample size is of 87 participants: 34 in the Revision Augmentation Cohort and 53 in the Primary Augmentation Cohort
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BellaSeno Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Owen Ung, Principal investigator, Royal Brisbane and Women's Hospital, Herston Biofabrication Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367698
- Sponsor's protocol ID
- 2025-BRV-005
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07367698
- Acronym / sponsor ID
- 2025-BRV-005
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Keywords
- Breast scaffold, PCL Scaffold, Absorbable Implant, Regenerative Medicine, Implant Removal, Breast Surgery, Clinical Safety and Performance, Primary Breast Augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- BellaSeno Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm study. Participants are enrolled into two predefined cohorts: * Revision Augmentation Cohort: Women that previously received breast augmentation using a breast implant(s) and require breast implant augmentation revision surgery or have received breast implant explantation without replacement, meet the eligibility criteria and provide informed consent to participate in this study. * Primary Augmentation Cohort: Women undergoing their first breast procedure (no previous breast implants), meet the eligibility criteria and provide informed consent to participate in this study. All participants receive the same investigational device. The sample size is of 87 participants: 34 in the Revision Augmentation Cohort and 53 in the Primary Augmentation Cohort
| Arm | Type | Receives |
|---|---|---|
| Implantation of the PCL Breast scaffold with autologous fat grafting | Experimental | Device: Implantation of the PCL Breast scaffold with autologous fat graftingImplantation of the PCL Breast Scaffold with autologous fat graft for breast implant revision or for primary breast augmentation surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of the PCL Breast scaffold with autologous fat graftingThe 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. | Device | Implantation of the PCL Breast scaffold with autologous fat grafting |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Professor Owen Ung principal investigator
Royal Brisbane and Women's Hospital, Herston Biofabrication Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of the PCL Breast scaffold with autologous fat grafting in people with Breast Implant Revision and Breast Augmentation Complications, run by BellaSeno Pty Ltd at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Owen Ung (+61 736460177, owen.ung@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.