A Clinical Study of Chinese Domestic Surgical Robot

Learn more about:
Related Clinical Trial
Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis Prognostic Indicators as Provided by the EPIC ClearView WSES International Register of Emergency Surgery Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections. Prospective Validation of “Cholecystectomy First” Strategy for Gallstone Migration ONSD According to the Position During Laparoscopy Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy Drainage or Not for Laparoscopic Cholecystetomy UDCA for Symptomatic Gallstone Disease Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Transvaginal Cholecystectomy Using Endoscopic Assistance Doripenem in the Treatment of Complicated Intra-Abdominal Infections Doripenem in the Treatment of Complicated Intra-Abdominal Infections The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy Evaluation of PC 6 “Neiguan” With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy. Role of the Right Portal Pedicle and Rouviere’s Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. NOTES-Assisted Laparoscopic Cholecystectomy Surgery EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy Fluorescence Cholangiography During Cholecystectomy – a RCT Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA FALCON: a Multicenter Randomized Controlled Trial Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy 3D Versus 4K Laparoscopic Cholecystectomy Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy Effect of Modified Stylet Angulation on the Intubation With GlideScope® Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor BDD With UDCA Therapy After Laparoscopic Cholecystectomy Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy Postoperative Pain Results According to Pressure to Form Pneumoperitoneum Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®) Prediction of Postoperative Pain by Injection Pain of Propofol Transient ECG Changes in Patients With Acute Biliary Disease Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy Establishing Visualization Grading Scale on LESS Cholecystectomy Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy A Clinical Study of Chinese Domestic Surgical Robot Laparoscopic Cholecystectomy: Study of Left Side of Laparoscopic Cholecystectomy Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Effects of Drainage in Laparoscopic Cholecystectomy Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain Early Versus Delayed Cholecystectomy If Chronic Gallbladder Diseases Increase the Incidence of PEC Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy — Use in Acute Cholecystitis Sub-Study The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy Enhanced Recovery in Laparoscopic Cholecystectomy Empirical Antibiotics in Acute Inflammatory Gallbladder Disease Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement. Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms Bile Aspiration vs Drain in Acute Cholecystitis Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis Fluorescent Cholangiography During Acute Cholecystitis Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder? Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy Scoring System in Acute Calculous Cholecystitis Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? Fast Track Pathway to Accelerated Cholecystectomy Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA) Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study. Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis. Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis The Role of Ultrasound in Cholecystitis AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis The Real World of Acute Cholecystitis Functional MRC With Eovist for Acute Cholecystitis FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

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 Information


Recruitment Status

Device

Estimated Enrollment

168

Start Date

October 13, 2019

Completion Date

November 1, 2020

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., +86 15974267868, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


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 2019