A Clinical Study of Chinese Domestic Surgical Robot
Prospective, Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial Protocol for the Safety and Efficacy of Clinical Applications of the Endoscopic Instrument Control System
This is a prospective, multi-center, randomized, single-blind, parallel-controlled clinical trial to evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.
To evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.This clinical trial is a prospective, multi-center, randomized, single-blind, parallel-controlled study. The system used in the experimental group is the endoscopic instrument control system developed by WEGO Surgical Robot Co., Ltd., and the system used in the control group is the da Vinci endoscopic instrument control system developed by Intuitive Surgical. Before patients are enrolled in this clinical study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the clinical study. Patients who meet the conditions of the study will be required to sign an informed consent form. Then they will be randomly assigned to the experimental group or the control group. To evaluate the primary outcome measures and secondary outcome measures and to observe the incidence of organ and vascular injury. Finally, we evaluate the safety and efficacy of the test product through the comparison of the data obtained from the experimental group and the control group during the treatment.
surgical success rate
The breakage rate of gallbladder
the MicroHand S endoscopic instrument control system
Study Arms / Comparison Groups
Description: MicroHand S robotic surgery group
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
October 13, 2019
October 1, 2021
Primary Completion Date
October 1, 2020
Inclusion Criteria: 1. 18-65 years old, male or female 2 .American Society of Anesthesiologists (ASA): Level 1, Level 2 or Level 3 3. BMI 18-30Kg/m2 4. Benign gallbladder diseases such as acute or chronic cholecystitis, gallstones and polypoid lesions of gallbladder 5. Subjects or their legal representatives/guardians voluntarily participate in clinical trials and have signed informed consent form Exclusion Criteria: 1. Participating in any other clinical trial within 30 days before signing the informed consent form 2. Pregnancy or lactation 3. With a history of epilepsy or psychosis 4. With a history of previous operations at related sites 5. Severe cardiovascular and cerebrovascular diseases with New York grade III-IV cardiac function or pulmonary insufficiency that can't tolerate the operation 6. Severe liver and kidney insufficiency such as cirrhosis and renal failure 7. Acute cholecystitis lasting for more than 72 hours, acute cholecystitis with severe complications such as cholecystitis, gangrene, perforation, etc., and gallbladder thickness thicker than 10 mm 8. Acute cholangitis, gallstone with acute pancreatitis, primary common bile duct stones, intrahepatic bile duct stones and obstructive jaundice 9. Gallbladder cancer or protuberant lesions are suspected to be cancerous 10. Severe allergic constitution and suspected or identified addicts to alcohol or drugs 11. Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic diseases 12. Other situations that researchers consider it inappropriate to participate in this clinical trial
18 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Shaihong Zhu, M.D., ,
The Third Xiangya Hospital of Central South University
The Affiliated Hospital of Qingdao University
Shaihong Zhu, M.D., Principal Investigator, The Third Xiangya Hospital of Central South University