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Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System

A Single-center, Prospective, Parallel Randomized Controlled Study Evaluating the Clinical Effectiveness of an Intelligent Graphic Report System for Upper Gastrointestinal Endoscopy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05851885
Enrollment
125
Registered
2023-05-10
Start date
2023-05-20
Completion date
2024-05-20
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Endoscopy, Gastrointestinal

Brief summary

The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.

Interventions

DIAGNOSTIC_TESTAI-based reporting system

AI-based reporting system is a software platform for real-time analysis and records of abnormalities and landmarks during endoscopy.

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Completeness of reporting lesionsone monthCalculation method = number of report lesions / total number of lesions x 100%

Secondary

MeasureTime frameDescription
Accuracy of report drafting on lesion featuresone monthCalculation method = number of accurately drafted features of lesions / total number of drafted features x 100%
Reporting timeone monthThe time that endoscopists draft reports
Completeness of report drafting on lesion featuresone monthCalculation method = number of drafted features of lesions / total number of features required to be drafted x 100%
Accuracy of report drafting on lesion features of AI systemone monthCalculation method = number of accurately drafted features of lesions / total number of drafted features x 100%
Physician satisfaction surveyone monthUse 5-point Likert scale to assess physician satisfaction, acceptance, and trust in using the intelligent graphic report system to draft endoscopic reports.
Completeness of reporting lesions of AI systemone monthCalculation method = number of report lesions / total number of lesions x 100%

Contacts

Primary ContactHonggang Yu, MD
yuhonggang1968@163.com+8613871281899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026