Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System
- Conditions
- Pathologic Stage I Gastric Cancer AJCC v8Colorectal CancerEsophageal CancerHepatectomyRadical Hysterectomy
- Interventions
- Procedure: Robot-assisted surgery
- Registration Number
- NCT06587152
- Lead Sponsor
- Cornerstone Robotics
- 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 in general, gynaecological and thoracic surgical procedures.
- Detailed Description
The trial was designed using a prospective, multi-centre, single-group target value approach.
For subjects who intend to undergo general surgery, gynaecological surgery and thoracic 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 in the above three disciplines, and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment of the above three disciplines.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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).
- Women who are pregnant or nursing an infant.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Robot-assisted surgery Robot-assisted surgery Robot-assisted thoraco-laparoscopic esophagectomy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The surgeon's operating time during the surgery Operative time（minutes）
Length of postoperative stay up to 12 weeks Total number of days the patient was in hospital from the day of surgery to discharge.
Intraoperative blood loss during the surgery Estimated blood loss（milliliters，ml）
Length of stay The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively. The postoperative day when patients complied with the predefined discharge criteria
Trial Locations
- Locations (1)
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China