NCT02500537已完成不适用
A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.
研究概览
简要总结
A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.
详细描述
The objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in subjects undergoing indicated abdominal or thoracic procedures.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be 18-80 years of age
- •The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
- •The subject is undergoing an indicated primary abdominal or thoracic procedure where the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) will be used per its Instructions For Use (IFU)
- •Thoracic procedures may include, but are not limited to, wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
- •Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection.
- •For thoracic subjects: the subject has a FEV1 ≥40%
排除标准
- •Subjects undergoing cardiac and vascular procedures
- •The procedure is an emergency procedure
- •The procedure is a revision/reoperation for the same indication
- •Any female subject who is pregnant
- •a. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test (except for subjects who are surgically sterile or are post-menopausal for at least two years)
- •Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
- •The subject is unable or unwilling to comply with the study requirements or follow-up schedule
- •The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
- •The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment
- •The subject is concurrently enrolled in an investigational drug or device research study
结局指标
主要结局
The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.
时间窗: Through 30 Days
次要结局
- Staple Line Assessment: Incidence of Post-operative Infection(Participants will be followed for the duration of hospital stay, on average up to 5 days)
- Staple Line Assessment: Duration of Leakage, Post-Op(Participants will be followed for the duration of hospital stay, on average up to 5 days)
- Staple Line Assessment: Incidence of Leakage(Day 0)
- Staple Line Assessment:(Participants will be followed for the duration of hospital stay, on average up to 5 days post-op)
- Staple Line Assessment: Incidence of Leakage; Post-Op(Participants will be followed for the duration of hospital stay, on average up to 5 days)
- Incidence of Repeat Hospital Admissions for Procedural-related Complications(30 Days following procedure)
- Staple Line Assessment: Incidence of Staple Line Bleeding(Day 0)
研究者
研究点 (1)
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