Study on the Effectiveness of Gastroscope Operation Quality Control Based on Artificial Intelligence Technology

November 28, 2023 updated by: Peng Yuan, Peking University
This study aims to construct a real-time quality monitoring system based on artificial intelligence technology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastroscopy plays an important role in the detection and diagnosis of upper gastrointestinal diseases. It is necessary for endoscopists to operate gastroscope according to the standardized process, in order to avoid missing early lesions. However, with the rapid increase in the number of endoscopies, the workload of endoscopists increases further. High workload reduces the quality of endoscopy, resulting in incomplete observation of anatomical parts that are easy to be missed in the process of gastroscopy. There are significant differences in the operation level of different endoscopists. Therefore, carrying out artificial intelligence methods has good academic research and practical value for improving the quality of endoscopic diagnosis and treatment.

Artificial intelligence devices need to use a large number of endoscopic images, based on this, we intends to collect endoscopic image data from our hospitals for training and validation of the model.

Study Type

Observational

Enrollment (Actual)

1570

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
    • Haidian
      • Beijing, Haidian, China, 100142
        • Beijing Cancer Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who meet the criteria for gastroscopy examination.

Description

Inclusion Criteria:

  1. Patiens aged 18 years or above undergoing gastroscopy；
  2. Be able to read, understand and sign informed consent；

Exclusion Criteria:

  1. Patients with absolute contraindications to endoscopy examination;
  2. pregnant women;
  3. previous history of gastric surgery;
  4. the researcher considers that the subject is not suitable for clinical trial.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: 2020.2.22-2020.7.1
Calculate the accuracy of AI's judgment on images
2020.2.22-2020.7.1
Sensitivity
Time Frame: 2020.2.22-2020.7.1
number of images in which AI correctly diagnosed positive/all images with positive
2020.2.22-2020.7.1
Specificity
Time Frame: 2020.2.22-2020.7.1
number of images in which AI correctly diagnosed negative/all images negative
2020.2.22-2020.7.1

Collaborators and Investigators

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

Sponsor

Peking University

Investigators

  • Study Chair: Qi Wu, MD., Peking University Cancer Hospital & Institute

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)

February 22, 2020

Primary Completion (Actual)

January 13, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PX2020047

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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