Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System

Sponsor

Renmin Hospital of Wuhan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05851885

Collaborator

(none)

125

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopy, Gastrointestinal Artificial Intelligence	Diagnostic Test: AI-based reporting system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 20, 2023

Anticipated Primary Completion Date :

Apr 20, 2024

Anticipated Study Completion Date :

May 20, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Completeness of reporting lesions [one month]
Calculation method = number of report lesions / total number of lesions x 100%

Secondary Outcome Measures

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%
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%
Reporting time [one month]
The time that endoscopists draft reports
Completeness of reporting lesions of AI system [one month]
Calculation method = number of report lesions / total number of lesions x 100%
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%
Physician satisfaction survey [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

EGD contraindications
Not suitable for sedated endoscopy after anaesthesia evaluation
Biopsy contraindications
Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
Pregnancy
Upper gastrointestinal surgery or residual stomach
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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Renmin Hospital of Wuhan University

ClinicalTrials.gov Identifier:

NCT05851885

Other Study ID Numbers:

EA-23-007

First Posted:

May 10, 2023

Last Update Posted:

May 10, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 10, 2023