Breast Implant RevisionNCT07383012
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
An observational study of Breast Implant Revision, run by BellaSeno Pty Ltd at 1 site in Australia.
Trial summary
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with autologous fat grafting (AFG) in the 2021-BRV-004 clinical trial (ClinicalTrials.gov ID… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Implant Revision
- How many people
- 19 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2026to Feb 2029
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who took part in the 2021-BRV-004 study, meet the eligibility criteria and provide informed consent to participate in this study
Who may be able to join
- Patients implanted with at least one PCL Breast Scaffold who took part in the 2021-BRV-004 study.
- Patients who provide written informed consent to participate in this study.
Who cannot join
- Patient unwilling and unable to comply with the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
Brisbane, Queensland, Australia, 4029
Professor Owen Ung, +61 736460177, owen.ung@health.qld.gov.au
Professor Owen Ung
About this study
Official title: Long-term Follow-up Study to Evaluate the Long-term Safety and Performance of PCL Breast Scaffolds Used for Breast Implant Revision Surgery in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with autologous fat grafting (AFG) in the 2021-BRV-004 clinical trial (ClinicalTrials.gov ID: NCT05437757). In addition, this study will investigate the suitability of mammography in the subset of patients that fall into the national breast screening age category - individuals aged 40 years and older.
The main questions this study aims to answer are:
Read more
- "Is the PCL Breast Scaffold combined with autologous fat grafting a safe and effective method of soft-tissue reconstruction following breast implant revision?"
- "Is mammography a suitable follow-up screening and diagnostic tool for patients implanted with the PCL Breast Scaffold?"
Participants will attend annual follow-up visits from 3 to 5 years after PCL Breast Scaffold implantation for clinical assessments and patient-reported outcome questionnaires.
- Conditions
- Breast Implant Revision
- Keywords
- Breast scaffold, PCL scaffold, Long-term Safety and Performance, Absorbable Implant, Regenerative Medicine, PCL breast scaffold, Mammography screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCL Breast Scaffold Follow-up Group | Participants from the 2021-BRV-004 study receiving long-term follow-up assessments at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of moderate and severe device-related (probable and causal) AEs rate
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 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Secondary outcomes (7)
Breast revision surgery rate
Number of breast revision surgeries categorized by reason and time
Measured: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
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 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Total breast volume retention (3D Imaging)
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 the 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 3- and 5-years after implantation of the PCL Breast Scaffold
Assessment of patient satisfaction, quality of life, body image, and psychological well-being using the validated BREAST-Q questionnaire
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.
Measured: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
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-, 4- and 5-years after implantation of the PCL Breast Scaffold
Assessment of device user experience using a 5-point Likert scale questionnaire
The 5-point Likert scale questionnaire is administered to the PI. Scores range from 1 to 5, with higher scores indicating greater surgeon satisfaction.
Measured: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Assessment of suitability of mammography after scaffold implantation
Visibility of glandular breast tissue; visibility of all regions of interest required for effective screening; any interference caused by the scaffold that may affect the sensitivity and specificity of the diagnostic method; visibility of the scaffold or regenerated tissue; visibility of any findings previously detected by (DCE-)MRI; and visibility of any liquid formation or seroma, if present.
Measured: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 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 (RBWH), Herston Biofabrication Institute (HBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383012
- Sponsor's protocol ID
- 2025-BRV-006
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2026
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study to Evaluate the Long-term Safety and Performance of PCL Breast Scaffolds Used for Breast Implant Revision Surgery in 2021-BRV-004
- ClinicalTrials.gov ID
- NCT07383012
- Acronym / sponsor ID
- 2025-BRV-006
- Conditions
- Breast Implant Revision
- Keywords
- Breast scaffold, PCL scaffold, Long-term Safety and Performance, Absorbable Implant, Regenerative Medicine, PCL breast scaffold, Mammography screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- BellaSeno Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 3 Feb 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 this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with autologous fat grafting (AFG) in the 2021-BRV-004 clinical trial (ClinicalTrials.gov ID: NCT05437757). In addition, this study will investigate the suitability of mammography in the subset of patients that fall into the national breast screening age category - individuals aged 40 years and older.
The main questions this study aims to answer are:
- "Is the PCL Breast Scaffold combined with autologous fat grafting a safe and effective method of soft-tissue reconstruction following breast implant revision?"
- "Is mammography a suitable follow-up screening and diagnostic tool for patients implanted with the PCL Breast Scaffold?"
Participants will attend annual follow-up visits from 3 to 5 years after PCL Breast Scaffold implantation for clinical assessments and patient-reported outcome questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCL Breast Scaffold Follow-up Group | – | –Participants from the 2021-BRV-004 study receiving long-term follow-up assessments at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who took part in the 2021-BRV-004 study, meet the eligibility criteria and provide informed consent to participate in this study
Key inclusion criteria (2 listed)
- Patients implanted with at least one PCL Breast Scaffold who took part in the 2021-BRV-004 study.
- Patients who provide written informed consent to participate in this study.
Key exclusion criteria (1 listed)
- Patient unwilling and unable to comply with the study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of moderate and severe device-related (probable and causal) AEs rate
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time
7 secondary outcomes
Breast revision surgery rate
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Rate and severity of all AEs related to device and/or procedure
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Total breast volume retention (3D Imaging)
Time frame: Assessed at 3- and 5-years after implantation of the PCL Breast Scaffold
Assessment of patient satisfaction, quality of life, body image, and psychological well-being using the validated BREAST-Q questionnaire
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
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-, 4- and 5-years after implantation of the PCL Breast Scaffold
Assessment of device user experience using a 5-point Likert scale questionnaire
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Assessment of suitability of mammography after scaffold implantation
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
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 30 Sep 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 (RBWH), Herston Biofabrication Institute (HBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant Revision, 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 Sep 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?
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?
Assessment of moderate and severe device-related (probable and causal) AEs rate (time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold). 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 30 Sep 2026.