Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 20
- 主要终点
- Time to Air Leak Cessation
研究概览
简要总结
VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Eligible subjects will be randomized to receive either Spiration Valves (investigational arm) or continue standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves should be removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS)
- •Subject has air leak present on at least the 5th day following origination.
排除标准
- •Subject has air leak only on forced exhalation or cough
- •Subject has sepsis
- •Subject has pneumonia
- •Subject has Acute Respiratory Distress Syndrome (ARDS)
- •Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
- •Subject has undergone a bone marrow transplant
- •Subject has a primary pneumothorax
- •Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.
研究组 & 干预措施
Spiration Valve System
The treatment group will have valves deployed to achieve leak isolation.
干预措施: Spiration Valve System (Device)
Medical Management
The control group for this study will receive standard chest tube drainage management and standard-of-care interventions. This group will be evaluated and followed in the same manner as the treatment group, but without having valves placed.
结局指标
主要结局
Time to Air Leak Cessation
时间窗: Two weeks
次要结局
未报告次要终点