NCT01328899已完成1 期
Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- St. George's Respiratory Questionnaire
研究概览
简要总结
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 35 years of age
- •bilateral heterogenous emphysema
- •Patient has stopped smoking for a minimum of 8 weeks
- •Read, understood and signed the Informed consent form
排除标准
- •Patient has a history of recurrent significant respirator infection
- •Patient has an inability to walk > 140 meters
- •Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
- •Patient is pregnant or lactating
- •Patient has clinical significant bronchiectasis
- •Patient has had previous LVR surgery, lung transplant or lobectomy
- •Patient has been involved in other pulmonary drug studies within 30 days prior to this study
结局指标
主要结局
St. George's Respiratory Questionnaire
时间窗: 6 months
Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline
次要结局
未报告次要终点
研究者
研究点 (11)
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