NCT00684684已完成1 期
A Safety and Feasibility Study of the Chartis System During Diagnostic Bronchoscopy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 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 during bronchoscopy.
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
- •Scheduled to undergo clinically indicated routine diagnostic bronchoscopy
排除标准
- •Hyperexcretive chronic bronchitis or excessive sputum secretion
- •Active pulmonary infection
- •FEV1 <20% predicted
- •FVC <50% predicted
研究组 & 干预措施
1
Experimental
干预措施: Chartis System (Device)
结局指标
主要结局
Adverse events
时间窗: Until discharge or 24 hours post procedure
次要结局
- Technical success(During procedure)
研究者
研究点 (1)
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