NCT01153074已完成不适用
Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas with devices originally developed for correction of cardiac septal defects deployed through bronchoscopic procedures.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 14 years old
- •Bronchopleural fistulas
排除标准
- •Clinical conditions increasing surgical risk (hemodynamic instability, respiratory distress)
- •Immunosuppressed patients
- •Acute intense inflammatory process in fistula edge
- •Suppurative pleural cavity infection
结局指标
主要结局
Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder
时间窗: 1 year
The closure of the fistulas will be bronchoscopically observed at regular intervals: one week, three weeks, two months and six months. At the third months post intervention, a thorax CT scan will ascertain the correct position and stability of the device.
次要结局
未报告次要终点
研究者
Miguel L. Tedde
MD, PhD
University of Sao Paulo
研究点 (3)
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