Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 主要终点
- Surgical non-referral rate
研究概览
简要总结
Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery
详细描述
This trial adopts a prospective, multicenter, single-arm objective value design.For subjects scheduled to undergo thoracoabdominal endoscopic surgery system-assisted laparoscopic surgeries in the departments of urology, general surgery, gynecology and thoracic surgery, the thoracoabdominal endoscopic surgery system developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. will be used to perform remote laparoscopic surgeries in the above four departments, and the efficacy and safety of the investigational medical device in the treatment of remote laparoscopic surgeries in these four departments will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age ≥ 18 and ≤ 80 years;
- •Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).
- •Subjects voluntarily participate in the clinical trial, and subjects or their guardians give informed consent and sign the informed consent form.
- •Willing to cooperate with and complete trial follow-ups and relevant examinations.
排除标准
- •Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.);
- •With other malignancies or a previous history of other malignancies.
- •Preoperative imaging suggests that the tumour has distant metastases.
- •The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment.
- •Severe bleeding tendencies or coagulopathic disorders.
- •With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
- •Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
- •Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
结局指标
主要结局
Surgical non-referral rate
时间窗: during the surgery
Surgical untransferred is defined as not converted from an experimental medical device assisted method to another surgical device control system assisted, laparoscopic surgery or open surgery.
次要结局
- The surgeon's operating time(during the surgery)
- Intraoperative blood loss(during the surgery)
- Length of stay(The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.)