NCT00684892已完成1 期
A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Heterogeneous emphysema as determined by high-resolution CT scan
- •Scheduled for clinically indicated ELVR procedure
排除标准
- •Hyperexcretive chronic bronchitis or excessive sputum secretion
- •Active pulmonary infection
- •Active asthma or lung hyper-responsiveness
结局指标
主要结局
Adverse events
时间窗: Until end of study procedure
次要结局
- Technical success(During procedure and up 1 week post procedure)
研究者
研究点 (2)
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