Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality

Artificial Intelligence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851716
• Other study ID #: EA-23-006
• Status: Recruiting
• Start date: August 21, 2023
• Est. completion date: May 20, 2024

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 20, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• 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

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

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