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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Assessment of moderate and severe device-related (probable and causal) AEs rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient unwilling and unable to comply with the study requirements.
研究组 & 干预措施
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
结局指标
主要结局
Assessment of moderate and severe device-related (probable and causal) AEs rate
时间窗: 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
次要结局
- Breast revision surgery rate(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(Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold)
- Total breast volume retention (3D Imaging)(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(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(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(Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold)
- Assessment of suitability of mammography after scaffold implantation(Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold)