NCT01520064终止不适用
Post Market Registry Study of the AeriSeal System
Aeris Therapeutics12 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2012年2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
- 25
- 试验地点
- 12
- 主要终点
- Post Market Registry Study of the AeriSeal System
研究概览
简要总结
- Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
- Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.
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
- •Advanced Emphysema
- •AeriSeal System treatment
排除标准
- •have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
- •have had frequent COPD exacerbations within the past year
- •require mechanical ventilatory support
- •have a pretreatment DLCO < 20% predicted or > 60% predicted
- •have a pretreatment FEV1 < 20% predicted AND homogeneous emphysema
- •have giant bullae
- •have undergone lung transplantation, lung volume reduction surgery, or lobectomy
- •are intolerant of corticosteroids or antibiotics
- •are pregnant or breast-feeding
结局指标
主要结局
Post Market Registry Study of the AeriSeal System
时间窗: At least 4 years
-Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-martet setting
次要结局
未报告次要终点
研究者
研究点 (12)
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