Breast Implant RevisionNCT05437757
Scaffold-guided Breast Surgery
A study testing Surgical implantation of the PCL Breast scaffold with autologous fat grafting in people with Breast Implant Revision and Congenital Breast Defect Correction, run by BellaSeno Pty Ltd at 1 site in Australia.
Trial summary
The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a absorbable frame to support this growth of cells. The scaffold will be absorbed within at least 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Implant Revision, Congenital Breast Defect Correction
- What is being tested?
- Surgical 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
- 19 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Jun 2022to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Females over the age of 18 requiring pre-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral.
- Patient willing and able to comply with the study requirements.
- Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
- Patient capable of providing valid informed consent.
- Patient has sufficient body fat for homologous transplantation.
Who cannot join
- Patients who have undergone Radical Mastectomy or radical removal of chest wall soft tissue.
- Patients who have had breast or chest wall irradiation.
- Prior history of infection in the breast region in the preceding 12 months.
- Patients diagnosed with or having a prior history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
- The patient has any condition or disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability.
- Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
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- Known severe concurrent or inter-current illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Co-ordinating Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.
- Body mass Index (BMI) below 20 and above 30 (patients with a BMI above 30 may still be eligible pending assessment by investigating team and documentation of rationale).
- Polycaprolactone (PCL) allergy
- Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the breast surgery.
- Patient ineligible to undergo MRI.
- Patient unable or unwilling to comply with the treatment protocol.
- Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
- Patients with a history of smoking (patients with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Brisbane and Women's Hospital (RBWH)
Brisbane, Queensland, QLD 4029
About this study
Official title: Clinical Trial Evaluating Medical-grade Polycaprolactone-PCL Breast Scaffold Implantation With Autologous Fat Grafting for Breast Implant Revision and Congenital Defect Correction Surgery
The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a absorbable frame to support this growth of cells. The scaffold will be absorbed within at least 3 years. The main assumption of this clinical trial is that the method used is safe and effective for treatment of women requiring a silicone implant and /or correction of breast defect and/or deformity. The other assumption is that this method is applicable to a wider range of tissue defects, such as breast reconstruction after breast tissue removal. The new method is called '3D printed scaffold-based soft tissue regeneration', and uses a combination of own fat cells (called adipocytes) with a 3D printed scaffold to support soft tissue regeneration using the natural healing processes in their body. This substance is absorbable and is similar to the substance used for sutures and stitches that are dissolvable or absorbable in the body. The substance used for the scaffold is already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the their own tissue in its place. The combination of scaffold implantation and their own fat cells is the novel method in this trial. Conventional liposuction techniques are used from another site on the patients body to harvest their fat cells.
Read the detailed description
A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted for breast revision an/or congenital defect correction. First the patient will be thoroughly evaluated with history taking and examination to determine whether they are suitable for implantation. If deemed suitable for the trial, the surgeon together with the patient will choose the right scaffold size and fix a date for the surgery. All scaffolds are sterilized and transported in sealed packaging.
The implantation surgery will be done at a tertiary teaching hospital by an experienced breast surgeon and plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction techniques usually harvesting from the abdomen and thighs depending on availability of tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of initial implantation. The total length of procedure is estimated to take 2 hours.
Recovery from the operation can take up to one week. From that, the effectiveness, complications and side-effects will be monitored for up to two years. The patient progress will be evaluated daily after the procedure while they are in hospital with clinical assessment of the wounds and overall status. On discharge a number of surveys will be performed to document the progress at regular intervals, as well as MRI studies. The duration of follow up for the study is 2 years after implantation.
All appointments and clinical assessments will be documented in the electronic patient medical record as well as electronic Case Report Form (QH-REDCap database).
- Being tested
- Surgical implantation of the PCL Breast scaffold with autologous fat grafting
- Keywords
- Breast scaffold, PCL Scaffold, Absorbable Implant, Regenerative Medicine, Implant Removal, Clinical Safety and Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical implantation of the PCL Breast scaffold with autologous fat graftingDevice
Single shot of prophylactic perioperative antibiotics is given to the patient. A suitable incision is made to provide access followed by mobilisation of the breast gland.If present, the silicone implant is removed and capsulectomy performed. The implant pocket shall be rinsed with saline or antiseptic and a surgical drain shall be placed in the pocket at the discretion of the PI. The PCL Breast scaffold shall be inserted into the pocket and fixed using 2 to 4 sutures. The incision is closed. Liposuction is performed from another area of the body and lipofilling is performed within the breast scaffold. Sterile bandaging is applied and a daily wound revision is performed whilst an inpatient. A prophylactic antibiotic shall be administered to the patient.The patients shall be hospitalized overnight for clinical observation.
| Study group | Role | What they receive |
|---|---|---|
| Implantation of PCL Breast scaffold | Experimental | Insertion of a 3D printed medical-grade polycaprolactone-PCL Breast scaffold with autologous fat graft for unilateral or bilateral breast implant revision and congenital defect correction surgery. Receives: Device: Surgical 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.
Post-operative device safety
Feasibility assessed through post-operative device safety measured through the adverse device effect rate (ADE rate). Adverse events are defined as per EN ISO 14155:2020. This will be regularly monitored during impatient and outpatient follow up.
Measured: Assessed at 12- and 24-months post-surgery.
Secondary outcomes (6)
Adverse Event rate and severity
Adverse events and severity are defined as per EN ISO 14155:2020. Regularly monitored during inpatient and outpatient follow up.
Measured: Assessed daily during inpatient stay at 1-week, 2-,6-,12- and 24-months post-surgery.
Frequency of complication
Composite outcome of short term and long term complications. This will be regularly monitored during inpatient and outpatient follow up.
Measured: Short term complications will be assessed at 1-week and 2-months follow-up visits.Long term complications will be assessed at 6-months, 12-months and 24-months follow-up visits.
Number of revision surgeries due to Adverse Device Effects
Adverse events are defined as per EN ISO 14155:2020. This will be regularly monitored during inpatient and outpatient follow up.
Measured: Assessed daily during inpatient stay, at 1-week, 2-,6-,12- and 24-months post-surgery.
Frequency of successful breast surgeries
This will be assessed as a composite outcome of:
- Number of successful surgeries,
- Clinical images (photographs, 3D scan, 180° video).
Measured: The frequency of successful breast surgeries will be assessed at the 24-month visit. The outcome of the surgeries will be assessed at enrolment and at 1-week, 2-, 6-, 12- and 24-month post-surgery.
QoL score obtained from BREAST-Q
It will be measured using the BREAST-Q questionnaire.
Scales:
Quality of Life:
- Physical Well-Being: Chest
- Psychosocial Well-Being
- Sexual Well-Being
Satisfaction:
- Breasts
Measured: Assessed at enrolment and at 2-,6-,12- and 24-months post-surgery.
Volume replacement
This will be assessed as a composite outcome of:
- Sternal notch to nipple (SN-N) measured in centimeters with tape measure and calipers
- Breast Base Width (BBW) measured in centimeters with tape measure and calipers
- Breast Height measured in centimeters with tape measure and calipers
- Nipple to IMF-(N-IMF) measured in centimeters with tape measure and calipers
- MRI (breast volume, scaffold volume and fat volume within scaffold measured in cc)
- MRI with contrast (only at 24-month post-surgery)
Measured: Assessed at enrolment and at 2-, 6-, 12- and 24-month post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start15 Jun 2022
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- BellaSeno Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Owen Ung, Principal investigator, Comprehensive Breast Cancer Institute (CBCI), Royal Brisbane and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437757
- Sponsor's protocol ID
- 2021-BRV-004
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng M, Chapman G, Wagels M, Ung O. Protocol for single-arm clinical trial evaluating medical grade polycaprolactone breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgery. BMJ Open. 2025 Apr 29;15(4):e088151. doi: 10.1136/bmjopen-2024-088151.
PubMed 40306907
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 Trial Evaluating Medical-grade Polycaprolactone-PCL Breast Scaffold Implantation With Autologous Fat Grafting for Breast Implant Revision and Congenital Defect Correction Surgery
- ClinicalTrials.gov ID
- NCT05437757
- Acronym / sponsor ID
- 2021-BRV-004
- Keywords
- Breast scaffold, PCL Scaffold, Absorbable Implant, Regenerative Medicine, Implant Removal, Clinical Safety and Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BellaSeno Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 29 Jun 2022 (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 clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a absorbable frame to support this growth of cells. The scaffold will be absorbed within at least 3 years. The main assumption of this clinical trial is that the method used is safe and effective for treatment of women requiring a silicone implant and /or correction of breast defect and/or deformity. The other assumption is that this method is applicable to a wider range of tissue defects, such as breast reconstruction after breast tissue removal. The new method is called '3D printed scaffold-based soft tissue regeneration', and uses a combination of own fat cells (called adipocytes) with a 3D printed scaffold to support soft tissue regeneration using the natural healing processes in their body. This substance is absorbable and is similar to the substance used for sutures and stitches that are dissolvable or absorbable in the body. The substance used for the scaffold is already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the their own tissue in its place. The combination of scaffold implantation and their own fat cells is the novel method in this trial. Conventional liposuction techniques are used from another site on the patients body to harvest their fat cells.
Detailed description
A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted for breast revision an/or congenital defect correction. First the patient will be thoroughly evaluated with history taking and examination to determine whether they are suitable for implantation. If deemed suitable for the trial, the surgeon together with the patient will choose the right scaffold size and fix a date for the surgery. All scaffolds are sterilized and transported in sealed packaging.
The implantation surgery will be done at a tertiary teaching hospital by an experienced breast surgeon and plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction techniques usually harvesting from the abdomen and thighs depending on availability of tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of initial implantation. The total length of procedure is estimated to take 2 hours.
Recovery from the operation can take up to one week. From that, the effectiveness, complications and side-effects will be monitored for up to two years. The patient progress will be evaluated daily after the procedure while they are in hospital with clinical assessment of the wounds and overall status. On discharge a number of surveys will be performed to document the progress at regular intervals, as well as MRI studies. The duration of follow up for the study is 2 years after implantation.
All appointments and clinical assessments will be documented in the electronic patient medical record as well as electronic Case Report Form (QH-REDCap database).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of PCL Breast scaffold | Experimental | Device: Surgical implantation of the PCL Breast scaffold with autologous fat graftingInsertion of a 3D printed medical-grade polycaprolactone-PCL Breast scaffold with autologous fat graft for unilateral or bilateral breast implant revision and congenital defect correction surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females over the age of 18 requiring pre-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral.
- Patient willing and able to comply with the study requirements.
- Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
- Patient capable of providing valid informed consent.
- Patient has sufficient body fat for homologous transplantation.
Key exclusion criteria (14 listed)
- Patients who have undergone Radical Mastectomy or radical removal of chest wall soft tissue.
- Patients who have had breast or chest wall irradiation.
- Prior history of infection in the breast region in the preceding 12 months.
- Patients diagnosed with or having a prior history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
- The patient has any condition or disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability.
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 |
|---|---|---|
| Surgical implantation of the PCL Breast scaffold with autologous fat graftingSingle shot of prophylactic perioperative antibiotics is given to the patient. A suitable incision is made to provide access followed by mobilisation of the breast gland.If present, the silicone implant is removed and capsulectomy performed. The implant pocket shall be rinsed with saline or antiseptic and a surgical drain shall be placed in the pocket at the discretion of the PI. The PCL Breast scaffold shall be inserted into the pocket and fixed using 2 to 4 sutures. The incision is closed. Liposuction is performed from another area of the body and lipofilling is performed within the breast scaffold. Sterile bandaging is applied and a daily wound revision is performed whilst an inpatient. A prophylactic antibiotic shall be administered to the patient.The patients shall be hospitalized overnight for clinical observation. | Device | Implantation of PCL Breast scaffold |
Primary outcome
Post-operative device safety
Time frame: Assessed at 12- and 24-months post-surgery.
Feasibility assessed through post-operative device safety measured through the adverse device effect rate (ADE rate). Adverse events are defined as per EN ISO 14155:2020. This will be regularly monitored during impatient and outpatient follow up.
6 secondary outcomes
Adverse Event rate and severity
Time frame: Assessed daily during inpatient stay at 1-week, 2-,6-,12- and 24-months post-surgery.
Frequency of complication
Time frame: Short term complications will be assessed at 1-week and 2-months follow-up visits.Long term complications will be assessed at 6-months, 12-months and 24-months follow-up visits.
Number of revision surgeries due to Adverse Device Effects
Time frame: Assessed daily during inpatient stay, at 1-week, 2-,6-,12- and 24-months post-surgery.
Frequency of successful breast surgeries
Time frame: The frequency of successful breast surgeries will be assessed at the 24-month visit. The outcome of the surgeries will be assessed at enrolment and at 1-week, 2-, 6-, 12- and 24-month post-surgery.
QoL score obtained from BREAST-Q
Time frame: Assessed at enrolment and at 2-,6-,12- and 24-months post-surgery.
Volume replacement
Time frame: Assessed at enrolment and at 2-, 6-, 12- and 24-month post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 40306907Cheng M, Chapman G, Wagels M, Ung O. Protocol for single-arm clinical trial evaluating medical grade polycaprolactone breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgery. BMJ Open. 2025 Apr 29;15(4):e088151. doi: 10.1136/bmjopen-2024-088151.
- 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. This study is not recruiting at the moment.
Owen Ung principal investigator
Comprehensive Breast Cancer Institute (CBCI), Royal Brisbane and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical implantation of the PCL Breast scaffold with autologous fat grafting in people with Breast Implant Revision and Congenital Breast Defect Correction, run by BellaSeno Pty Ltd at 1 site 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 5 inclusion and 14 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: finished, 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative device safety (time frame: Assessed at 12- and 24-months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437757, which also lists 1 linked publication.
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.