Bronchoscopic Lung Volume Reduction With Endobronchial Silicone Valve for Patients With Emphysema: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in 1-second (FEV1)
研究概览
简要总结
The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve 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 optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group. 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 after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.
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
研究组 & 干预措施
ESV and Optimal Medical Management
This study arm will undergo ESV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
干预措施: ESV (Device)
Optimal Medical Management
This study arm will undergo optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
干预措施: Optimal Medical Management (OMM) (Other)
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