A Clinical Study of Chinese Domestic Surgical Robot

Central South University

Status: Completed

Conditions: Cholecystitis; Gallstone

Treatments: Device: the da Vinci endoscopic instrument control system; Device: the MicroHand S endoscopic instrument control system

Study type: Interventional

Funder types: Other

Identifiers

NCT04122261

SDWG-NST600S-CT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

experimental group

Experimental group

Description:

MicroHand S robotic surgery group

Treatment:

Device: the MicroHand S endoscopic instrument control system

control group

Experimental group

Description:

da Vinci robotic surgery group

Treatment:

Device: the da Vinci endoscopic instrument control system