Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality

August 31, 2023 updated by: Renmin Hospital of Wuhan University

A Prospective, Single-arm, Single-center Observational Study to Evaluate the Clinical Effectiveness of an Intelligent Reporting System for the Upper Gastrointestinal Endoscopy

The goal of this observational study is to evaluate the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The main question it aims to answer is: Whether the AI-based reporting system can improve the completeness of the reports, which are drafted by endoscopists with the AI assistance. Participants will undergo upper gastrointestinal endoscopy examination as routine. The junior endoscopists will draft the report with the assiatance of the AI system. And the senior and expert endoscopists will draft the report using the traditional reporting system without AI assistance.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population is not limited. Patients aim to undergo screening, surveillance, and diagnosis upper gastrointestinal endoscopy will be accessed for eligibility.

Description

Inclusion Criteria:

  1. Aged 18 years
  2. Aim to undergo screening, surveillance, and diagnosis
  3. Undergo sedated EGD
  4. Able to read, understand, and sign informed consent

Exclusion Criteria:

  1. EGD contraindications
  2. Not suitable for sedated endoscopy after anaesthesia evaluation
  3. Biopsy contraindications
  4. Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
  5. Pregnancy
  6. Upper gastrointestinal surgery or residual stomach
  7. Not suitable for recruitment after investigator evaluation because of other high-risk conditions

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
Completeness of reporting lesions
Time Frame: one month
Calculation method = number of report lesions / total number of lesions x 100%
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of report drafting on lesion features
Time Frame: one month
Calculation method = number of drafted features of lesions / total number of features required to be drafted x 100%
one month
Accuracy of report drafting on lesion features
Time Frame: one month
Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%
one month
Reporting time
Time Frame: one month
The time that endoscopists draft reports
one month
Completeness of reporting lesions of AI system
Time Frame: one month
Calculation method = number of report lesions / total number of lesions x 100%
one month
Accuracy of report drafting on lesion features of AI system
Time Frame: one month
Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%
one month

Collaborators and Investigators

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

Sponsor

Renmin Hospital of Wuhan University

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)

August 21, 2023

Primary Completion (Estimated)

April 20, 2024

Study Completion (Estimated)

May 20, 2024

Study Registration Dates

First Submitted

April 30, 2023

First Submitted That Met QC Criteria

April 30, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EA-23-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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