Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot-assisted surgery.
- Who it may be relevant to
- Registry conditions: Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer, Esophageal Cancer, Hepatectomy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Trial to Evaluate the Efficacy and Safety of Endoscopy System for General Surgery, Gynecology and Thoracic Surgery
Overview
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.
Interventions
- Procedure Robot-assisted surgery
Surgery with the Cornerstone Surgical Robot.
Primary outcome measures
- Surgical non-referral rate [Time frame: during the surgery]
Secondary outcome measures (4)
- The surgeon's operating time [Time frame: during the surgery]
- Length of postoperative stay [Time frame: up to 12 weeks]
- Intraoperative blood loss [Time frame: during the surgery]
- Length of stay [Time frame: The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.]
Eligibility criteria
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).
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine — Hangzhou
Publications
- Park JY, Ryu KW, Reim D, Eom BW, Yoon HM, Rho JY, Choi IJ, Kim YW. Robot-assisted gastrectomy for early gastric cancer: is it beneficial in viscerally obese patients compared to laparoscopic gastrectomy? World J Surg. 2015 Jul;39(7):1789-97. doi: 10.1007/s00268-015-2998-4. PMID 25670040
- Somashekhar SP, Deshpande AY, Ashwin KR, Gangasani R, Kumar R, Shetty S. Comparative Evaluation of the Short-Term Treatment Outcomes Between Open, Laparoscopic- and Robotic-Assisted Surgical Approaches for Rectal Cancer Treatment. Indian J Surg Oncol. 2020 Dec;11(4):649-652. doi: 10.1007/s13193-020-01137-z. Epub 2020 Jul 10. PMID 33299282
Identifiers
NCT: NCT06587152 · F-00359-002