AI-assisted Endoscopy Report System In Improving Reporting Quality

Artificial Intelligence Clinical Trial

Official title:

A Single-center Study of an AI-assisted Endoscopy Report System In Improving Reporting Quality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479253
• Other study ID #: EA-21-010
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, MD
• Phone: 13871281899
• Email: yuhonggang1969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for endoscopy report quality in endoscopists. The subjects would be divided into two groups. For the collected endoscopic videos, group A would complete the endoscopy report with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture images, prompt abnormal lesions and the parts covered by the examination (the upper gastrointestinal tract is divided into 26 parts). Group B would complete the endoscopy report without special prompts. After a period of forgetting, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the endoscopy report. Then, the completeness of the report lesion, the accuracy of the lesion location, the completeness of the lesion and the standard part in the captured images, and so on were compared with or without AI assistance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Males or females who are over 18 years old;

2. After qualified medical education and obtained the Certificate of Chinese medical practitioner;

Exclusion Criteria:

1. Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner;

2. The researcher believes that the subjects are not suitable for participating in clinical trials.

Related Conditions & MeSH terms

• Artificial Intelligence
• Endoscopy

Intervention

Diagnostic Test:
• Artificial intelligence assistant system
The artificial intelligence assistant system can automatically capture images, prompt abnormal lesions and the parts covered by the examination (the stomach is divided into 26 parts).

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan

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	Integrity of report lesion	Report lesion integrity with or without AI-assisted. Calculation method = number of report lesions / total number of lesions x 100%	one month
Primary	Accuracy of lesion location	Accuracy of lesion location with or without AI-assisted. Calculation method = number of lesion with correct location / total number of lesions x 100%	one month
Primary	Integrity of lesion in captured images	Lesion integrity in captured images with or without AI-assisted. Calculation method = number of lesions in captured images / total number of lesions x 100%	one month
Primary	Integrity of standard part in captured images	Lesion integrity in captured images with or without AI-assisted. Calculation method = number of standard parts in captured images / the actual number of standard parts covered by the examination x 100%	one month