NCT03140098撤回不适用
Evaluation of the Tolerance and Efficacy of COVA™+ CARD in Adult Cardiac Surgery. A Prospective, Observational and Single Center Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Evaluation of the tolerance of COVA™+ CARD in cardiac surgery
研究概览
简要总结
The aim of this observational study is to evaluate the safety of the guided healing and adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery. The causality of the collagen membrane according to the occurrence of peri and post-operative complications will be evaluated.
详细描述
Assessment of the safety of COVA™+ CARD, collagen membrane to prevent adhesion appearance, in cardiac surgery in adult patients:
- collection of post-operative complications, causality of the membrane
- collection of complications in the 3-month period after the surgery, causality of the membrane
- collection of peri-operative complications, causality of the membrane
- collection of complications, 3 months after the surgery
- assessment of the efficacy of COVA™+ CARD if re-operation
- assessment of the surgeon's satisfaction
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Cardiac surgery using COVA™+ CARD
排除标准
- •In accordance with the instruction for use (IFU) of the medical device.
- •Refusal of participation to the study
结局指标
主要结局
Evaluation of the tolerance of COVA™+ CARD in cardiac surgery
时间窗: 3 months
Recording of complications reported in the 3-month postoperative period and determination of the causality of the collagen membrane.
次要结局
- Evaluation of the tolerance of COVA™+ CARD in cardiac surgery(Hospitalization stay (up to 30 days))
研究者
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