NCT01784822已完成不适用
Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 5
- 主要终点
- Rate of hernia recurrence
研究概览
简要总结
The objective this study is to collect post-market data on the performance of the Zenapro™ Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or recurrent ventral hernia
- •Need for abdominal wall repair with reinforcement or bridging material to obtain the desired surgical result
排除标准
- •Age < 21 (i.e., infants, children)
- •Device intended to be used in an infected wound
- •Known sensitivity to porcine material
- •Pregnant or planning pregnancy in the future
- •Life expectancy of less than 12 months from the date of the index procedure
- •Hernia too large to be covered with a single device with at least 4-5 cm of tissue overlap on all sides
结局指标
主要结局
Rate of hernia recurrence
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (5)
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