Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System

April 30, 2023 updated by: Renmin Hospital of Wuhan University

A Single-center, Prospective, Parallel Randomized Controlled Study Evaluating the Clinical Effectiveness of an Intelligent Graphic Report System for Upper Gastrointestinal Endoscopy

The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

125

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 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

Yes

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Physicians draft EGD reports with the assistance of the AI-based reporting system.
Diagnostic test: AI-based reporting system
AI-based reporting system is a software platform for real-time analysis and records of abnormalities and landmarks during endoscopy.
No Intervention: Control group
Physicians use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.

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
Physician satisfaction survey
Time Frame: one month
Use 5-point Likert scale to assess physician satisfaction, acceptance, and trust in using the intelligent graphic report system to draft endoscopic reports.
one month

Collaborators and Investigators

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

Sponsor

Renmin Hospital of Wuhan University

Investigators

  • Principal Investigator: Honggang Yu, MD, Wuhan University Renmin Hospital

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 (Anticipated)

May 20, 2023

Primary Completion (Anticipated)

April 20, 2024

Study Completion (Anticipated)

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)

May 10, 2023

Last Update Submitted That Met QC Criteria

April 30, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EA-23-007

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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