NCT06677008尚未招募不适用
Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Anastomosis success rate
研究概览
简要总结
This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.
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
- •Age unlimited and gender unlimited;
- •The surgery type shall be endoscopic surgery;
- •The departments of surgical procedures: general and thoracic surgical procedures;
- •Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.
排除标准
- •Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen;
- •Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;
- •Surgery record is incomplete, unable to extract main indicators related information.
结局指标
主要结局
Anastomosis success rate
时间窗: the investigation sites will be collected from January 2023 to September 2024.
The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.
次要结局
- Operation time(The investigation sites will be collected from January 2023 to September 2024.)
- Amount of intraoperative blood loss(the investigation sites will be collected from January 2023 to September 2024.)
- Intraoperative conversion (caused by the stapler and/or cartridge)(the investigation sites will be collected from January 2023 to September 2024.)
- Length of hospitalization(the investigation sites will be collected from January 2023 to September 2024.)
- All-cause re-hospitalization rate (within 6 months)(From the date of surgery to six months after the surgery)
研究者
研究点 (1)
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