NCT07842406尚未招募不适用
A Retrospective, Multi-center, Observational, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone IVTE Range of Silicone Breast Expanders When Used for Breast Reconstruction.
GCA (Eurosilicone)0 个研究点目标入组 100 人开始时间: 2026年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Rate of reconstruction failure
研究概览
简要总结
Patients can undergo breast reconstruction surgery in two stages before implantation of the permanent prosthesis for several reasons. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants.
This study is designed to collect data on Integrated valve tissue expander to assess the performance and safety data on this device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Subjects aged ≥18
- •Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:
- •Reconstruction of the breast following subcutaneous mastectomy and other mastectomy procedures or trauma.
- •Breast underdevelopment and combined breast and chest wall abnormalities.
- •Scar/defect revision
- •Subjects who have received a Eurosilicone IVTE.
排除标准
- •Subjects with contra-indication to the surgery or not filling Instruction for Use (IFU) indications, contra-indications.
结局指标
主要结局
Rate of reconstruction failure
时间窗: 2 years after the tissue expander implantation surgery
Reconstruction failure means that the definitive reconstructive surgery (breast implant or autologous reconstruction) either did not take place or was unsuccessful.
次要结局
未报告次要终点
研究者
相似试验
尚未招募
不适用
A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-MastectomyBreast Reconstruction After MastectomyNCT07602868West China Hospital263
招募中
不适用
A Study of a Decision Tool for People Considering Breast Reconstruction SurgeryBreast CancerNCT07335354Memorial Sloan Kettering Cancer Center131
招募中
不适用
“A study comparing post surgery outcomes in two types of breast implants used in reconstruction after a mastectomy: one placed above the chest muscle (prepectoral) and one placed below the chest muscle (subpectoral)â€CTRI/2024/10/074797AIIMS NEW DELHI30
招募中
不适用
DIEP Flap Breast Reconstruction: Perioperative Biomarkers and OutcomesBreast NeoplasmsIschemia-Reperfusion InjuryPostoperative ComplicationsWound HealingOxidative StressInflammationNCT07263347Hubei Cancer Hospital30
招募中
不适用
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular ContractureCapsular Contracture of Breast ImplantNCT07810231Research Inc3,000