Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery

Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery

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.

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

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.