NCT00950872已完成不适用
A Prospective, Single-Center Investigation of the Safety and Performance of the ENDO GIA Staplers With ENDO GIA Single Use Loading Units With DUET TRS TM in a Gastric Bypass Procedure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events.
研究概览
简要总结
The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.
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
- 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 18-65 years of age.
- •The patient has a BMI of 40-60 kg/m2 or 35-40 kg/m2 with comorbidities
- •The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.
排除标准
- •The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
- •The patient is pregnant.
- •The patient has an active, or history of, infection at the operative site.
- •The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
- •Patient has an abdominal ventral hernia
- •The patient has a history of liver disease
- •The patient has a history of drug or alcohol abuse
- •The patient has a history of venous thrombosis or pulmonary embolism
- •The patient has a history of coagulopathy
研究组 & 干预措施
Duet TRS
Experimental
Subjects receive Duet TRS
干预措施: Duet TRS (Device)
结局指标
主要结局
Incidence of Adverse Events.
时间窗: Day 30
次要结局
- Operating Room (OR) Time(Day 0)
- Length of Hospital Stay(Day 2 (Approximately 1.5 days post randomization))
- Incidence of Stapler 'Misfires'(Day 0)
研究者
研究点 (1)
Loading locations...
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