NCT03615495已完成不适用
Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 12
- 主要终点
- Rate of Adverse Events
研究概览
简要总结
This study is continued evaluation of the safety and probable benefit of the Flourish Pediatric Esophageal Atresia device through the Humanitarian Device Exemption (HDE) pathway.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of Adverse Events
时间窗: 2 years
Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks
次要结局
未报告次要终点
研究者
研究点 (12)
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