- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07257796
Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score
The endoscopic grading system (EGGIM) has been widely used to assess the extent of gastric intestinal metaplasia during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically evaluate the extent of gastric intestinal metaplasia (GIM) and calculate the EGGIM scores in endoscopy examination. This study is a prospective, multi-center study aimed at exploring the performance and reliability of AI-EGGIM scoring.
This is a prospective study designed to validate the AI-EGGIM system in a larger cohort. The study protocol was developed based on preliminary experience from a prior investigation (NCT05464108).
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital of Shandong University
-
Contact:
- Zhen Li
- Phone Number: 18560086106
- Email: qilulizhen@sdu.edu.cn
-
Jinan, Shandong, China
- Not yet recruiting
- Shandong First Medical University First Affiliated Hospital
-
Jinan, Shandong, China
- Not yet recruiting
- Shandong Second Provincial General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients aged 40-75 years who undergo the IEE examination
- patients who voluntarily sign the informed consent form
Exclusion Criteria:
- patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
- patients with previous surgical procedures on the stomach
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance of AI system to diagnose the grade of intestinal metaplasia by calculating the EGGIM score
Time Frame: 1 year
|
The performance of the AI system will be evaluated in diagnosing the grade of gastric intestinal metaplasia (IM) based on the Endoscopic Grading of Gastric Intestinal Metaplasia (EGGIM) system.
EGGIM is a validated scoring method ranging from 0 to 10, reflecting the extent of IM across five gastric regions: two in the antrum, two in the corpus, and one at the incisura.
Each region is scored as 0 (no IM), 1 (focal IM, ≤30% of the area), or 2 (extensive IM, >30% of the area), with a total possible score of 10.
Higher EGGIM scores correspond to more severe IM and greater gastric cancer risk.
The AI-derived scores will be compared with expert' EGGIM scores, which serve as the gold standard, to assess diagnostic accuracy.
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025SDU-QILU-5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.