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临床试验/NCT07345013
NCT07345013已完成不适用

A Retrospective Study to Evaluate the Safety and Effectiveness of easyEndoTM Lite Staplers and Loading Units

Ezisurg Medical Co. Ltd.1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2021年1月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
900
试验地点
1
主要终点
stapling success rate

研究概览

简要总结

A retrospective, single-arm, observation study to Evaluate the clinical safety and performance of Ezisurg stapler in thoracic surgery, 900 patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.

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

性别
All
接受健康志愿者

入选标准

  • The study population were patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.

排除标准

  • 未提供

结局指标

主要结局

stapling success rate

时间窗: Perioperative/Periprocedural

No intrate-operative and post-operative air-leak

次要结局

  • Intraoperative blood loss(Perioperative/Periprocedural)
  • Rate of convert to open surgery(Perioperative/Periprocedural)
  • Hospitalization time(Perioperative/Periprocedural)
  • Incidence of postoperative complications(Perioperative/Periprocedural)
  • Readmission rate(30 days)

研究者

发起方
Ezisurg Medical Co. Ltd.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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