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Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality

Sponsor
Renmin Hospital of Wuhan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05851716
Collaborator
(none)
200
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Prospective, Single-arm, Single-center Observational Study to Evaluate the Clinical Effectiveness of an Intelligent Reporting System for the Upper Gastrointestinal Endoscopy
    Anticipated Study Start Date :
    May 20, 2023
    Anticipated Primary Completion Date :
    Apr 20, 2024
    Anticipated Study Completion Date :
    May 20, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Completeness of reporting lesions [one month]

      Calculation method = number of report lesions / total number of lesions x 100%

    Secondary Outcome Measures

    1. Completeness of report drafting on lesion features [one month]

      Calculation method = number of drafted features of lesions / total number of features required to be drafted x 100%

    2. Accuracy of report drafting on lesion features [one month]

      Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%

    3. Reporting time [one month]

      The time that endoscopists draft reports

    4. Completeness of reporting lesions of AI system [one month]

      Calculation method = number of report lesions / total number of lesions x 100%

    5. Accuracy of report drafting on lesion features of AI system [one month]

      Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Renmin Hospital of Wuhan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Renmin Hospital of Wuhan University
    ClinicalTrials.gov Identifier:
    NCT05851716
    Other Study ID Numbers:
    • EA-23-006
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 10, 2023