Zephyr Valve Japan Post-Marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 17
- 主要终点
- Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.
研究概览
简要总结
This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.
详细描述
This is a multicenter, prospective, observational surveillance across 20 centers in Japan enrolling 140 consecutive adult patients with hyperinflation of the lungs due to severe emphysema who are considered to be appropriate candidates for BLVR using Zephyr Endobronchial Valve (EBV, Pulmonx Corporation) and confirmed to have little to no collateral ventilation in the target lobe.
Enrolled (consented) subjects will undergo a bronchoscopy procedure with the Chartis assessment to confirm that little to no collateral ventilation is present (CV- status) followed by EBV placement in the most diseased lobe. Subject will be hospitalized for a minimum of 3 nights for observation and followed up for 12 months.
Subjects with collateral ventilation will be exited from the surveillance without treatment.
The primary endpoint is incidence rate of pneumothorax at Day 45 post-index procedure.
The effectiveness will be evaluated from Baseline to specified timepoint based on changes in lung function, exercise capacity, dyspnea and quality of life. A high-resolution computed tomography (HRCT) will be performed at Day 45 and Month 12 to determine Treated Lobe Volume Reduction (TLVR). Lung function will be assessed at Month 3, 6 and 12 by measuring post-bronchodilator forced expiratory volume in 1 second (FEV1), residual volume (RV) and 6 Minutes Walking Distance. The safety will be evaluated based on incident rate of treatment emergent adverse events through Month 12.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include:
- •Recent respiratory rehabilitation completed within the last 6 months
- •Not actively smoking (for at least 4 months)
- •TLC ≥ 100%
- •RV ≥ 175%
- •FEV1 15-45% post-bronchodilator
- •6MWD 100-500 m
- •mMRC score ≥ 2
- •No coagulation disorder
- •No evidence of active respiratory infection
- •Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.
- •Patient is willing and able to provide informed consent to allow data collection.
排除标准
- 未提供
结局指标
主要结局
Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.
时间窗: 45-days post-Zephyr Valve index procedure
The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.
次要结局
未报告次要终点