Evaluation of the Cinenses Lung Volume Reduction Reverser System in Treating Patients With Severe Emphysema
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness.
详细描述
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness. Study Population ：Patients with severe emphysema and have to meet all the inclusion and exclusion criteria.
Sample Size： 15 subjects
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of adverse events
时间窗: 3-month post final bronchoscopy
Evaluate adverse events associated with implantation of the Cinenses Lung Volume Reduction Reverser System at 3-month post final bronchoscopy. CinensesTMLung Volume Reduction Reverser System at 3-month post final bronchoscopy.
次要结局
- Device success (Device level)(immediate postoperative)
- Procedural success(during the hospital stay)
- Improvement in the mMRC dyspnea scale(1,3,6-month,12-month follow-up)
- St. George's Respiratory Questionnaire (SGRQ) score(1,3,6-month,12-month follow-up)
- Percent change in forced expiratory volume in 1 second(1,3,6-month,12-month follow-up)
- Decrease in the Residual Volume (RV)(1,3,6-month,12-month follow-up)
- Improvement in the 6-minute walk test(1,3,6-month,12-month follow-up)