Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Safety - device deficiencies
研究概览
简要总结
The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.
All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander.
The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE .
- •Patient has been informed correctly according to to the applicable national and local regulations.
排除标准
- •Not applicable
结局指标
主要结局
Safety - device deficiencies
时间窗: Until finalization of staged Breast reconstruction, approximately 6 months
Device-related complications include those resulting from any device failure, including those resulting in removal and/or replacement of the Motiva Flora® TE.
Performance - surgeon satisfaction
时间窗: Until finalization of staged Breast reconstruction, approximately 6 months
Surgeon's overall satisfaction with the results of the expansion according to the General Aesthetic Improvement Scale (GAIS), a 5-point Likert scale (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) after the completion of the breast reconstruction (after the second surgery (long-term breast implant).
Safety - adverse events
时间窗: Until finalization of staged Breast reconstruction, approximately 6 months
Cumulative incidence and causal relationship with the device of adverse events (AEs) reported by the surgeon. This includes known complications as listed in the IFU, as well as any other adverse events, seen as at least possibly related to the device according to the surgeon.
Performance - succesful implant of long-term breast implant
时间窗: Until finalization of staged Breast reconstruction, approximately 6 months
Successful tissue expander-based-breast reconstruction is measured by the fact that the second step of the staged procedure - the implantation of the long-term breast implant - could be performed or not as initially planned, as per surgeon judgement (Yes / No)
次要结局
- Length of hospitalization(Until discharge from hospital after first surgery (Motiva Flora Tissue Expander), approximately 1-2 days)
- Surgical difficulties - 2nd surgery (Long-term breast implant)(Intraoperative)
- Concomitant treatments - 1st surgery(Intraoperative)
- Concomitant treatments - 2nd surgery(Intraoperative)
- Surgical difficulties- 1st surgery (Motiva Flora TE implantation)(Intraoperative)