NCT07361939已完成不适用
Evaluation of the Safety and Effectiveness of easyEndoTM Lite Linear Cutting Stapler and Loading Unit in Gastrointestinal Surgery: a Retrospective, Observational, Post Market Study
Ezisurg Medical Co. Ltd.1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年3月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- stapling success rate
研究概览
简要总结
The purpose of this observational study is to evaluate the safety and performance of the easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit from EziSurg Medical in gastrointestinal surgery. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications retrospectively.
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
- 否
入选标准
- •Age at study entry is at least 18 years.
- •The operation involves the application of easyEndoTM Lite Stapler and Loading Unit for tissue cutting and suturing.
排除标准
- •Pregnancy.
- •Emergency operation (such as acute intestinal obstruction and gastrointestinal perforation).
- •Assessed by the investigator, whose condition is poor and cannot tolerate the surgery.
- •History of gastrointestinal surgery.
研究组 & 干预措施
easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit
Experimental
干预措施: easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit (Device)
结局指标
主要结局
stapling success rate
时间窗: Perioperative/Periprocedura
次要结局
- postoperative complications(Perioperative/Periprocedural)
- Technical success rate(Perioperative/Periprocedural)
研究者
研究点 (1)
Loading locations...
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