NCT02922205已完成不适用
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Duomed
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events related to the index-procedure.
研究概览
简要总结
The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age at study entry is at least 18 years.
- •Patient must sign and date the informed consent form prior to the index-procedure.
- •Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
- •Patient has a BMI ≥ 40 kg/m.
排除标准
- •Patient is pregnant.
- •History of bariatric surgery.
- •Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.
结局指标
主要结局
Number of patients with adverse events related to the index-procedure.
时间窗: 6 months follow-up
Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
次要结局
- Questionnaire on food tolerance.(1, 6, 12 and 24 month follow-up)
- Number of patients with bariatric surgery related re-interventions.(1, 6, 12 and 24 month follow-up)
- Percentage of excess weight loss.(1, 6, 12 and month follow-up)
- Number of adverse device effects.(1, 6, 12 and 24 month follow-up)
研究者
研究点 (1)
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