NCT01026103已完成不适用
A Prospective, Single-center Investigation of the Safety and Performance of the Endo GIA™ Stapler With Endo GIA™ Sulu With Tri-Staple™ Technology in a Gastric Bypass Procedure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Proportion of Patients With an Uneventful Creation of a Functional Staple Line
研究概览
简要总结
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
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 65 Years（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 one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass.
- •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 requiring mesh repair
- •The patient has a history of clinically significant liver disease
- •The patient has a history of drug or alcohol abuse within 2 years of enrollment
- •The patient has a history of venous thrombosis or pulmonary embolism
- •The patient has a history of coagulopathy
结局指标
主要结局
Proportion of Patients With an Uneventful Creation of a Functional Staple Line
时间窗: Day 0
次要结局
- Incidence of Intra-operative Bleeding Requiring Intervention(Day 0 and 1 month)
- Length of Hospital Stay(Date of discharge which averages 3 days)
- Incidence of Serosal Tearing(30 days post op)
研究者
研究点 (2)
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