NCT01806636终止不适用
Post Market Observational, Prospective, Multi-center Registry Using the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,275
- 试验地点
- 73
- 主要终点
- Changes in Quality of Life (QOL) measures
研究概览
简要总结
This registry is a post market observational, prospective, multi-center registry.
It is designed to evaluate patient experience with the endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in Quality of Life (QOL) measures
时间窗: 6 months and yearly up to three years post treatment 1
次要结局
- Changes in Pulmonary Function and Exercise Capacity test results(6 months and yearly up to three years post treatment 1)
- Safety including any device malfunction or failure(s)(6 months and yearly up to three years post treatment 1)
研究者
研究点 (73)
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