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A Clinical Study of Chinese Domestic Surgical Robot

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ClinicalTrials.gov Identifier: NCT04122261
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
The Affiliated Hospital of Qingdao University
Information provided by (Responsible Party):
The Third Xiangya Hospital of Central South University

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.

Condition or disease Intervention/treatment Phase
Gallstone Cholecystitis Device: the MicroHand S endoscopic instrument control system Device: the da Vinci endoscopic instrument control system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: experimental group
MicroHand S robotic surgery group
Device: the MicroHand S endoscopic instrument control system
Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.

Experimental: control group
da Vinci robotic surgery group
Device: the da Vinci endoscopic instrument control system
Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.




Primary Outcome Measures :
  1. surgical success rate [ Time Frame: within 24 hours after operation ]
    The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group.


Secondary Outcome Measures :
  1. The breakage rate of gallbladder [ Time Frame: within 12 hours after operation ]
    The breakage rate of gallbladder is defined as the proportion of the subjects in the experimental group or the control group with specimen breakage.

  2. Comprehensive Complication Index (CCI) [ Time Frame: an average of 5 days after operation ]
    CCI is calculated using online tools provided by http://cci.assessurgery.com. Based on the Clavien-Dindo complications grade system (appendix.1), all complications and adverse events after surgical intervention are taken into consideration. The overall incidence is measured on a scale ranging from 0 (no complication) to 100 (death).

  3. Operative time [ Time Frame: within 12 hours after operation ]
    The length of time from the beginning of the operation after the robot installation to the end of the suture of the incision.

  4. Intraoperative bleeding [ Time Frame: within 12 hours after operation ]
    The total bleeding volume from the beginning of the operation to the end of the suture of the incision. It can be calculated by measuring the blood volume in the vacuum suction device and weighing the gauze after using them to wipe the bleeding.

  5. Postoperative pain [ Time Frame: within 24 hours after operation ]
    Postoperative pain is assessed by visual analogue scale (VAS) 24-26 hours after the operation, ranging from 0 (no pain) to 10 (maximum pain).

  6. Time to first flatus [ Time Frame: an average of 2 days after operation ]
    The time from the end of the operation to the subject's first flatus after surgery.

  7. Surgeon's satisfaction [ Time Frame: within 12 hours after operation ]
    After the operation, surgeons fill a questionnaire to score the flexibility, intuition and stability of the products, as well as their sense of delay and fatigue when using the products. Each question in the score ranges from 1 to 5 points and the total score is 100.

  8. Installation time [ Time Frame: preoperation ]
    The time from the power-on of the products to the end of the connection between trocars and the operative arms.

  9. Hospital stay [ Time Frame: an average of 5 days after operation ]
    The total hospital days of subjects from admission to discharge.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122261


Contacts
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Contact: Shaihong Zhu, M.D. +86 15974267868 zshcsu@163.com

Locations
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China, Hunan
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410013
Contact: Shaihong Zhu, M.D.    +86 15974267868    zshcsu@163.com   
Principal Investigator: Shaihong Zhu, M.D.         
Sub-Investigator: Guohui Wang, M.D.         
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
The Affiliated Hospital of Qingdao University
Investigators
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Principal Investigator: Shaihong Zhu, M.D. The Third Xiangya Hospital of Central South University
  Study Documents (Full-Text)

Documents provided by The Third Xiangya Hospital of Central South University:
Statistical Analysis Plan  [PDF] September 1, 2019
Study Protocol  [PDF] September 1, 2019


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Responsible Party: The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT04122261     History of Changes
Other Study ID Numbers: SDWG-NST600S-CT
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholecystitis
Gallstones
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis
Cholecystolithiasis
Calculi
Pathological Conditions, Anatomical