Status:
COMPLETED
A Clinical Study of Chinese Domestic Surgical Robot
Lead Sponsor:
The Third Xiangya Hospital of Central South University
Collaborating Sponsors:
The Affiliated Hospital of Qingdao University
Conditions:
Gallstone
Cholecystitis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 cl...
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, par...
Eligibility Criteria
Inclusion
- 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
- Participating in any other clinical trial within 30 days before signing the informed consent form
- Pregnancy or lactation
- With a history of epilepsy or psychosis
- With a history of previous operations at related sites
- Severe cardiovascular and cerebrovascular diseases with New York grade III-IV cardiac function or pulmonary insufficiency that can't tolerate the operation
- Severe liver and kidney insufficiency such as cirrhosis and renal failure
- 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
- Acute cholangitis, gallstone with acute pancreatitis, primary common bile duct stones, intrahepatic bile duct stones and obstructive jaundice
- Gallbladder cancer or protuberant lesions are suspected to be cancerous
- Severe allergic constitution and suspected or identified addicts to alcohol or drugs
- Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic diseases
- Other situations that researchers consider it inappropriate to participate in this clinical trial
Key Trial Info
Start Date :
October 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04122261
Start Date
October 13 2019
End Date
October 1 2021
Last Update
October 25 2021
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013