Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The rate of intraoperative complications
研究概览
简要总结
This clinical study was a prospective, single-center, single-arm exploratory study. Subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform 5G remote gastrectomy on subjects using the Toumai endoscopic surgery system, and explore and evaluate the safety and efficacy of this clinical application.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ actual age ≤80 years old.
- •Patients requiring gastrointestinal endoscopic surgery.
- •Willing to cooperate with and complete the study follow-up and related examinations.
- •Voluntarily participate in the study and sign the informed consent in person.
排除标准
- •Have serious cardiovascular or circulatory disease and cannot tolerate surgery.
- •Participated in other clinical trials within the last 3 months.
- •Inability to understand trial requirements, or inability to complete the study follow-up plan.
- •Researchers believe that there are other circumstances that are not suitable for inclusion.
结局指标
主要结局
The rate of intraoperative complications
时间窗: The day of surgery
Intraoperative complications, including organ injury and vascular injury, were evaluated using the Satava grading system to determine whether the occurrence of complications was related to the study instrument or surgery
The rate of postoperative complications
时间窗: Postoperative 30 days
Postoperative complications, including postoperative bleeding, fever, and incisional infection, were evaluated using the Clavien-Dindo grading system to determine whether the occurrence of complications was related to the study instrument or surgery.
次要结局
- Surgical completion rate(The day of surgery)
- Intraoperative blood loss(The day of surgery)
- Operation time(The day of surgery)
- Preoperative device assembly time(The day of surgery)
- Intraoperative instrument operation error rate(The day of surgery)
- Intraoperative system failure rate(The day of surgery)
研究者
Qun Zhao
Principal Investigator
Hebei Medical University