Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- anastomosis success rate
研究概览
简要总结
This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.
详细描述
The disposable endoscopic linear cutting staplers and components developed and produced by Jiangsu Channel Medical Device Co., Ltd. can be used in open or endoscopic surgery of lung, bronchial tissue, stomach and intestine resection, transection and anastomosis. They have been registered in China for many years and have been widely used, and have been certified by the European Union in 2021. The number is CIM.2021.106.14629. This study intends to conduct a multi-center retrospective cohort study in China, collect clinical application data of Chinese patients, conduct statistical analysis on the clinical application data, confirm whether the expected effectiveness and safety are achieved, and further extrapolate to the EU population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gender unlimited, age unlimited ② open or endoscopic surgery ③ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.
- •use the study device during surgery
排除标准
- •patients with contraindications to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;
- •combined with other similar products (staplers) for surgical site excision, transsection and anastomosis; ③ surgical records are incomplete, and information related to major indicators cannot be extracted; ④ other situations that the researcher considers inappropriate for inclusion in the study.
结局指标
主要结局
anastomosis success rate
时间窗: within six months after surgery
According to surgical records and hospitalization records, the condition of no reoperation in situ was defined as successful anastomosis. Anastomosis success rate=cases of successful anastomosis/total cases of surgery ×100%
次要结局
未报告次要终点