NCT01220908已完成不适用
Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Quality of Life Assessment.
研究概览
简要总结
The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 35 years of age
- •unilateral or bilateral 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 clinically significant respiratory 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 clinically significant bronchiectasis
- •Patient has had previous LVR surgery, lung transplant or lobectomy
- •Patient has been involved in other pulmonary drug studies with 30 days prior to this study
- •Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
结局指标
主要结局
Quality of Life Assessment.
时间窗: Three + Months Follow-Up Visit
Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
撤回
不适用
Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin DeficiencyAlpha-1-Antitrypsin DeficiencyChronic Obstructive Lung DiseaseEmphysemaNCT02273349University Hospital, Saarland
已完成
2 期
Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Subjects with Homogeneous EmphysemaEmphysemaNL-OMON35800PneumRx10
已完成
不适用
Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Emphysema.COPD10038716EmphysemaNL-OMON35583PneumRx, Inc20
已完成
1 期
Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)EmphysemaNCT01334307Boston Scientific Corporation47
已完成
2 期
Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous EmphysemaEmphysemaNCT01421082Boston Scientific Corporation10