Cervical Cancer, Endometrial Cancer
Conditions
Keywords
Cervical Cancer, Endometrial Cancer
Brief summary
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.
Detailed description
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
Interventions
DEVICERobot-assisted surgery
Surgery with the Cornerstone Surgical Robot.
Sponsors
Cornerstone Robotics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical non-referral rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The surgeon's operating time | During the surgery | Operative time（minutes） |
| Intraoperative blood loss | During the surgery | Estimated blood loss（milliliters，ml） |
| Length of postoperative stay | up to 12 weeks | Total number of days the patient was in hospital from the day of surgery to discharge. |
Countries
China
Outcome results
None listed