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A Clinical Study of Chinese Domestic Surgical Robot

NCT ID: NCT04122261

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-13

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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Gallstone Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental group

MicroHand S robotic surgery group

Group Type EXPERIMENTAL

the MicroHand S endoscopic instrument control system

Intervention Type DEVICE

Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.

control group

da Vinci robotic surgery group

Group Type EXPERIMENTAL

the da Vinci endoscopic instrument control system

Intervention Type DEVICE

Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.

Interventions

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the MicroHand S endoscopic instrument control system

Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaihong Zhu, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Locations

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The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

References

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Wang G, Yi B, Li Z, Zhu L, Hao L, Zeng Y, Zhu S. Micro-Hand Robot-Assisted Versus da Vinci Robot-Assisted Cholecystectomy: A Multi-centre, Randomized Controlled Trial. World J Surg. 2022 Nov;46(11):2632-2641. doi: 10.1007/s00268-022-06668-w. Epub 2022 Jul 20.

Reference Type DERIVED
PMID: 35857076 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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SDWG-NST600S-CT

Identifier Type: -

Identifier Source: org_study_id