The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)
研究概览
简要总结
The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. 18-85 years of age
- •ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50%
- •iii. Residual Volume (RV) > 175%
- •iv. 6 min walk test > 150 m
- •v. Completed a course of Pulmonary rehabilitation
- •vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR
- •vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU
排除标准
- •i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment
- •ii. Acute respiratory tract infections
- •iii. Significant bronchiectasis,
- •iv. Co-existing interstitial lung diseases, pneumothorax,
- •v. Known active malignancy
- •vi. Pregnancy.
结局指标
主要结局
Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)
时间窗: 4 weeks post lung sealant application
Collateral ventilation status will be functionally assessed and confirmed via CHARTIS® System. Examination of left upper lobe to determine percentage of participants converted from collateral ventilation positive to a collateral ventilation negative state
次要结局
- Number of participants with improved lung functioning as measured by lung function tests(12weeks and 52 weeks post valve implant)
- Changes Lung volume(12weeks and 52 weeks post valve implant)