Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement in pulmonary function (FEV1 and RV/TLC)
研究概览
简要总结
Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.
详细描述
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
- •heterogeneous emphysema
排除标准
- •homogeneous emphysema
- •significant bronchiectasis
- •severe concomitant diseases
- •pregnancy
结局指标
主要结局
Improvement in pulmonary function (FEV1 and RV/TLC)
时间窗: 6 months
次要结局
- Average changes in 6-minute-walk-distance(6 months)
- Evaluation of valve migration rate(6 months)
- Number of severe adverse events(6 months)
- Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)(6 months)
研究者
Felix JF Herth
Professor MD
Heidelberg University