Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality
A Prospective, Single-arm, Single-center Observational Study to Evaluate the Clinical Effectiveness of an Intelligent Reporting System for the Upper Gastrointestinal Endoscopy
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2023
CompletedFirst Posted
Study publicly available on registry
May 10, 2023
CompletedStudy Start
First participant enrolled
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2024
CompletedSeptember 5, 2023
August 1, 2023
8 months
April 30, 2023
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Completeness of reporting lesions
Calculation method = number of report lesions / total number of lesions x 100%
one month
Secondary Outcomes (5)
Completeness of report drafting on lesion features
one month
Accuracy of report drafting on lesion features
one month
Reporting time
one month
Completeness of reporting lesions of AI system
one month
Accuracy of report drafting on lesion features of AI system
one month
Eligibility Criteria
The study population is not limited. Patients aim to undergo screening, surveillance, and diagnosis upper gastrointestinal endoscopy will be accessed for eligibility.
You may qualify if:
- Aged 18 years
- Aim to undergo screening, surveillance, and diagnosis
- Undergo sedated EGD
- Able to read, understand, and sign informed consent
You may not qualify if:
- EGD contraindications
- Not suitable for sedated endoscopy after anaesthesia evaluation
- Biopsy contraindications
- Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
- Pregnancy
- Upper gastrointestinal surgery or residual stomach
- Not suitable for recruitment after investigator evaluation because of other high-risk conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2023
First Posted
May 10, 2023
Study Start
August 21, 2023
Primary Completion
April 20, 2024
Study Completion
May 20, 2024
Last Updated
September 5, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share