NCT04422236进行中（未招募）不适用
A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Duomed
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
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 when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by 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
- •Patient ≥ 18 years of age at registry entry.
- •Patient and investigator signed and dated the informed consent form prior to the index-procedure.
- •Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.
- •Patient has a BMI ≥ 40 kg/m
- •Patient is eligible for laparoscopic bariatric surgery.
排除标准
- •Patient is unable / unwilling to provide informed consent.
- •Patient has a history of bariatric surgery.
- •Patient is unable to comply with the registry protocol or proposed follow-up visits.
- •Patient has a contra-indication for laparoscopic bariatric surgery.
结局指标
主要结局
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
时间窗: Follow-up 6: 24 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
次要结局
- Device performance(At index procedure)
- Clinical efficacy(Follow-up 6: 24 months after the procedure)
研究者
研究点 (1)
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