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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05851716
Other study ID # EA-23-006
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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