NCT01483534已完成1 期
Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 5
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1 30% to 60%
- •FEV1/FVC <70%
- •Prior smoker (at least 10 pack years)
- •Quit smoking for at least 6 months
排除标准
- •Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
- •Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
- •Pulmonary nodule requiring surgery
- •Presence of implantable electronic devices
- •Active respiratory infection within recent weeks
- •COPD exacerbation within recent weeks
- •Recent Myocardial infarction (MI)
- •Recent and unstable or life threatening arrhythmia
- •Malignancy treated with radiation or chemotherapy within the last 2 years
- •Presence or clinical diagnosis of other respiratory diseases other than COPD
结局指标
主要结局
Primary Safety Endpoint
时间窗: 365 days post procedure
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
次要结局
- Technical Feasibility(At time of Treatment)
研究者
研究点 (5)
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