Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- FEV 1 6 Minute walk test
研究概览
简要总结
Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.
详细描述
Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too.
Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heterogenous emphysema
- •FEV1 < 45%
- •RV > 150%
- •TLC > 100%
- •TLCO < 40%
排除标准
- •Homogeneous emphysema
- •Pregnancy
- •PCO2 > 50 mmHg
结局指标
主要结局
FEV 1 6 Minute walk test
时间窗: 6 months after intervention
次要结局
- Safety Symptom scores(6 months after intervention)
研究者
Felix JF Herth
CEO
Heidelberg University