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临床试验/NCT00684892
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)

Pulmonx Corporation2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年5月最近更新:
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

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

申办方类型
Industry

研究点 (2)

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