Unilateral vs. Bilateral IBV Placement
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Improvement in pulmonary function (FEV1) 6-minute walking test
研究概览
简要总结
Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.
详细描述
Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •age > 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT > 150 m
排除标准
- •pregnant homogeneous disease FEV1 < 20%
结局指标
主要结局
Improvement in pulmonary function (FEV1) 6-minute walking test
时间窗: 3 months
次要结局
- Number of major complications(SAE)(3 months)
- Evaluation of the IBV migration rate(3 months)
- Average changes in quality of life (SGRQ)(3 months)
- Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)(3 months)