A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 26
- 主要终点
- Safety
研究概览
简要总结
Study to collect post-market safety data for HUD IBV Valve System, a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or LVRS. An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1)continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has an air leak present on day 7 after lobectomy, segmentectomy, or lung volume reduction surgery (LVRS), or on day 5 if the air leak is 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise
排除标准
- •Air leak only on force exhalation or cough
- •Subject has significant active asthma, pneumonia, bacterial bronchitis or clinically significant bronchiectasis
- •Subject is unable to provide informed consent and there is no designated authority to sign for the incapacitated patient
- •Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
- •Subject has co-morbidities or factors that will prevent follow-up during the study period
研究组 & 干预措施
Treatment with HUD IBV Valve System
Treatment with HUD IBV Valve System in Post-Approval Study
干预措施: Treatment with HUD IBV Valve System (Device)
结局指标
主要结局
Safety
时间窗: Day 0 to 6 weeks
The primary objective of this study is to characterize the device safety profile. Adverse events (AEs) reported during the study will be analyzed and summarized. This information will be used to enhance the HDE device labeling.
次要结局
- Probable Benefit(Day 0 to 6 weeks)