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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05479253
Other study ID # EA-21-010
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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