Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

January 28, 2020 updated by: Yanqing Li

Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms

The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.

Study Type

Interventional

Enrollment (Actual)

1060

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing EGD examination with anaesthesia;
  • patients able to give informed consent.

Exclusion Criteria:

  • patients with the contraindications to EGD examination;
  • patients with a prior EGD examination within 1 year before the trial;
  • patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;
  • a history of upper gastrointestinal cancers;
  • allergic to anaesthetic in previous medical history;
  • patients refused to participate in the trial;
  • the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EAS-aided group
esophagogastroduodenoscopy examination with the assistance of automatic quality-control system
Other: automatic quality-control system
Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.
NO_INTERVENTION: control group
conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection rate of gastric neoplasms
Time Frame: 8 months
detection rate of gastric neoplasms in different groups
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean number of gastric neoplasms detected
Time Frame: 8 months
mean number of gastric neoplasms detected per procedure in different groups
8 months
mean inspection completeness
Time Frame: 8 months
inspection completeness per procedure in different groups
8 months
mean inspection time
Time Frame: 8 months
inspection time per procedure in different groups
8 months
errors of EAS
Time Frame: 8 months
errors of EAS in EAS-aided group
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanqing Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2019

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (ACTUAL)

March 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019SDU-QILU-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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