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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold |
| Measure | Description | Time Frame |
|---|---|---|
| Breast revision surgery rate | Number of breast revision surgeries categorized by reason and time | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical possibility of MRI for tracking scaffold degradation | Visibility of ongoing degradation compared to previous visit through DCE-MRI | Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold |
| Assessment of suitability of US (if medically indicated) screening after scaffold implantation |
Inclusion Criteria:
Exclusion Criteria:
Female
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Participants who took part in the 2021-BRV-004 study, meet the eligibility criteria and provide informed consent to participate in this study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor Owen Ung | Contact | +61 736460177 | owen.ung@health.qld.gov.au |
| Name | Affiliation | Role |
|---|---|---|
| Professor Owen Ung | Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI) | Brisbane | Queensland, Australia | 4029 | Australia |
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Core biopsies may be performed during the study if clinically indicated. De-identified biopsy samples will be collected and stored only after obtaining participant consent.
Number of AEs categorised by relationship with device and/or procedure (possible, probable, causal), severity and type over time
| 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:
| 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. | 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. | 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. | 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. | Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold |
Visibility of all regions of interest required for effective screening; any interference caused by the scaffold that affects the Color Doppler US reporting; visibility of the scaffold or regenerated tissue; visibility of any findings previously detected by DCE-MRI; and visibility of any liquid formation or seroma, including estimation of US-based calculated volume when present. |
| Only if medically indicated between 3 and 5 years after implantation of the PCL breast scaffold. |
| Biopsy, if clinically indicated, will be used for assessment of: tissue viability, tissue composition, tissue vascularisation, inflammatory response | Assessments include tissue viability (presence of viable cells and observation of any necrotic tissue), tissue composition (tissue type, presence of calcifications or oil cysts), tissue vascularization (presence of blood vessels), and inflammatory response (presence of inflammation and whether it is acute or chronic) | Reccomended 3 years after implantation of the PCL Breast Scaffold |