Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Surgical non-referral rate
研究概览
简要总结
Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use ingynaecological surgical procedures.
详细描述
The trial was designed using a prospective, single-centre, single-group target value approach.
For subjects who intend to undergo gynaecological surgery assisted by the Thoracic and Abdominal Endoscopic Surgical System.
To use the Thoracic and Abdominal Endoscopic Surgical System developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. to perform surgery , and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years;
- •Body Mass Height Index (BMI) 18<BMI<30kg/㎡;
- •Patients identified by the investigator as suitable for general, gynaecological and thoracic surgery;
- •Written informed consent.
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).
- •With severe allergies and suspected or established alcohol, drug or substance addiction.
- •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 postoperative stay(up to 12 weeks)