A Clinical Study of Chinese Domestic Surgical Robot

Brief Title

A Clinical Study of Chinese Domestic Surgical Robot

Official Title

Prospective, Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial Protocol for the Safety and Efficacy of Clinical Applications of the Endoscopic Instrument Control System

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Type

Interventional

Primary Outcome

surgical success rate

Secondary Outcome

 The breakage rate of gallbladder

Condition

Gallstone

Intervention

the MicroHand S endoscopic instrument control system

Study Arms / Comparison Groups

 experimental group

Description:  MicroHand S robotic surgery group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

168

Start Date

October 13, 2019

Completion Date

October 1, 2021

Primary Completion Date

October 1, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Shaihong Zhu, M.D., , 

Location Countries

China

Location Countries

China

NCT ID

NCT04122261

Organization ID

SDWG-NST600S-CT

Responsible Party

Sponsor

Study Sponsor

The Third Xiangya Hospital of Central South University

Collaborators

 The Affiliated Hospital of Qingdao University

Study Sponsor

Shaihong Zhu, M.D., Principal Investigator, The Third Xiangya Hospital of Central South University

Verification Date

October 2021