NCT01716598已完成1 期
IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.
Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.
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%
- •Patient is diagnosed with COPD
- •Positive relative change in FEV1 of greater than 15%
- •Patient 40 years of age or older at the time of consent
- •Smoking history of at least 10 pack years
- •Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study
排除标准
- •Documented history or current evidence of pulmonary hypertension Documented history or current evidence of polycythemia level of greater
- •Documented history or current evidence of congestive heart failure
- •Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa (55 mm Hg) on room air
- •Patient has a PaCO2 > 8.0 kPa (60 mm Hg)
- •Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy
- •Pulmonary nodule requiring surgery
- •History of recurrent respiratory infections (more than 3 hospitalizations within 1 year of enrollment)
- •Presence of a pacemaker, internal defibrillator or other implantable electronic devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m. Unstable or life threatening arrhythmia within the last year n. Malignancy treated with radiation or chemotherapy within the last 2 years o. Documented history of other respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 365 Days
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
- Performance(365 days)
研究者
研究点 (5)
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