Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System

Artificial Intelligence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05851885
• Other study ID #: EA-23-007
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: April 2023
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, MD
• Phone: +8613871281899
• Email: yuhonggang1968[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: May 20, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artificial Intelligence
• Endoscopy, Gastrointestinal

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completeness of reporting lesions	Calculation method = number of report lesions / total number of lesions x 100%	one month
Secondary	Completeness of report drafting on lesion features	Calculation method = number of drafted features of lesions / total number of features required to be drafted x 100%	one month
Secondary	Accuracy of report drafting on lesion features	Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%	one month
Secondary	Reporting time	The time that endoscopists draft reports	one month
Secondary	Completeness of reporting lesions of AI system	Calculation method = number of report lesions / total number of lesions x 100%	one month
Secondary	Accuracy of report drafting on lesion features of AI system	Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%	one month
Secondary	Physician satisfaction survey	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