NCT03968757已完成不适用
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery: a Monocentric Post-market Observational Study
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
- 150
- 试验地点
- 1
- 主要终点
- To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
研究概览
简要总结
The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB 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
- Case Only
- 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. If the patient is not able to give informed consent, a legally authorized representative must give informed consent on his/her behalf.
- •Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
- •Patient has a BMI ≥ 40 kg/m2.
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 (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
结局指标
主要结局
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
时间窗: at 24 months follow-up
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.
次要结局
- To evaluate the efficacy of the laparoscopic RYGB surgery(at 24 months follow-up)
- To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)(at index-procedure)
- To evaluate the performance of the easyEndoTM Universal Linear Cutting(at index-procedure)
研究者
研究点 (1)
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