A Prospective, Multi-Center Evaluation of Endo GIA Staplers With Endo GIA Single Use Loading Units (SULUs) With Duet TRS TM in a Pulmonary Resection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- The primary objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days)in an anatomic pulmonary resection.
研究概览
简要总结
The objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIA Staplers with ENDO GIA Single Use Loading Units (SULUs) buttressed with Duet TRS TM in an anatomic pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS). Anatomic pulmonary resection is defined as either a lobectomy or segmental resection. Results of the study will be compared to contemporary literature for a similar population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •The patient must be 18 years of age or older
- •The patient must be scheduled to undergo segmentectomy or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer
- •The patient must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure
- •The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.
排除标准
- •The patient is pregnant or breastfeeding
- •The patient is scheduled to undergo sleeve lobectomy, wedge resection, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease
- •The patient has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected
- •The patient is scheduled to receive intra-operative brachytherapy
- •The patient has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months
- •Re-operative surgery is excluded if it is on the same side as the previous surgery
- •The patient requires chest wall reconstruction
结局指标
主要结局
The primary objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days)in an anatomic pulmonary resection.
时间窗: intra-operative and 1 month follow up
次要结局
- The secondary objectives are length of hospital stay, duration of chest tube following surgery and need for Heimlich valve at discharge.(discharge and 1 month follow up)