NCT01449175终止不适用
A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema
Aeris Therapeutics8 个研究点 分布在 4 个国家目标入组 54 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 8
- 主要终点
- Change in number of Serious Adverse Events (SAE)
研究概览
简要总结
The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.
详细描述
The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced homogeneous or heterogeneous emphysema.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.
排除标准
- 未提供
结局指标
主要结局
Change in number of Serious Adverse Events (SAE)
时间窗: Weeks 48, 96, 120, 144 following treatment
Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety
次要结局
- Change in Vital Signs(weeks 48, 96, 120, 144 following treatment)
- Change in Oxygen (O2) Use(Weeks 48, 96, 120, 144 following treatment)
- Change in medications(week 48, 96, 120, 144 following treatment)
- Change in Pulmonary Function Tests (PFT)(Weeks 48, 96, 120, 144 following treatment)
- Change in notable radiology results(weeks 48, 96, 120, 144 following treatment)
研究者
研究点 (8)
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