LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Implant Revision. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Patient unwilling and unable to comply with the study requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 1 center
- Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI) — Brisbane
Identifiers
NCT: NCT07383012 · 2025-BRV-006