Bronchoscopic Lung Volume Reduction With Endobronchial Silicone Valve for Patients With Emphysema: a Randomised Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- China-Japan Friendship Hospital
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in 1-second (FEV1)
概览
简要总结
The purpose of this research is to compare the efficacy and safety between endobronchial silicone valve and endobronchial valve in bronchoscopic lung volume reduction in patients with severe emphysema.
详细描述
The Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) is a novel designed implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The ESV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.
This clinical trial included two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) with optimal medical therapy. The 'Control' group will receive Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.
It is hypothesized that the ESV has similar efficacy and safety to EBV in treating patients with severe emphysema.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological evidence of emphysema
- •Nonsmoking for 4 months prior to screening interview
- •BMI less than 35 kg/m2
- •Stable on current medication regimen
- •Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
- •Residual Volume less than 175% predicted (determined by body plethysmography)
- •Little or no collateral ventilation (CV-) as determined using the Chartis System
排除标准
- •Had two or more hospitalizations over the last year for a COPD exacerbation
- •Had two or more hospitalizations over the last year for pneumonia
- •Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
- •Had a heart attack or congestive heart failure within the last 6 months
- •Have heart arrhythmia
- •Is alpha-1 antitrypsin deficient
结局指标
主要结局
Forced Expiratory Volume in 1-second (FEV1)
时间窗: 1-year
Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).
次要结局
- 6-minute Walk Distance(1 year)
- FEV1 Post-bronchodilator Absolute Change(1 year)
- St. George's Respiratory Questionnaire (SGRQ)(1 year)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital