AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 444
- 试验地点
- 36
- 主要终点
- Safety Endpoints
研究概览
简要总结
The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.
详细描述
Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for an open thoracotomy for lung resection
- •Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery
排除标准
- •Pregnant or breast feeding
- •History of an allergic reaction to Human Serum Albumin
- •Has a significant clinical disease or condition
- •Had previous open thoracotomy procedures
- •Unable to participate in all necessary study activities due to physical or mental limitations
结局指标
主要结局
Safety Endpoints
时间窗: 90 days
* Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome * Renal adverse events * Cardiac adverse events * Death (all causes) * Hospital readmission
次要结局
未报告次要终点