Gastric Intestinal MetaplasiaNCT07208864
Efficacy of an AI System in Training Endoscopists to Assess Gastric Intestinal Metaplasia Via the EGGIM Score
A study testing AI-assisted EGGIM scoring and Conventional EGGIM scoring in people with Gastric Intestinal Metaplasia, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This prospective randomized controlled trial with a crossover design incorporated image-enhanced endoscopy (IEE) videos demonstrating complete standardized examinations of five standard gastric areas (antrum greater curvature, antrum lesser curvature, incisura, corpus lesser curvature, and corpus greater curvature). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Intestinal Metaplasia
- What is being tested?
- AI-assisted EGGIM scoring and Conventional EGGIM scoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Endoscopists who have performed ≥50 image-enhanced endoscopy (IEE) procedures per year and demonstrated competency in performing standardized IEE.
Who cannot join
- Endoscopists who participated in data acquisition or were unblinded to patients' identifiable information and clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
About this study
Official title: Efficacy of an AI System in Training Endoscopists to Assess Gastric Intestinal Metaplasia Via the EGGIM Score: A Randomized Controlled Trial
This prospective randomized controlled trial with a crossover design incorporated image-enhanced endoscopy (IEE) videos demonstrating complete standardized examinations of five standard gastric areas (antrum greater curvature, antrum lesser curvature, incisura, corpus lesser curvature, and corpus greater curvature). Endoscopists were stratified by experience level and randomly assigned to either the AI-assisted scoring first group, which performed EGGIM scoring with AI assistance in the initial phase followed by conventional scoring after a washout period, or the conventional scoring first group, which completed the assessments in reverse order. The study primarily evaluated the training efficacy of the EGGIM-AI system for improving endoscopists' EGGIM scoring performance by comparing diagnostic accuracy metrics, including the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity between groups at different study phases.
- Conditions
- Gastric Intestinal Metaplasia
- Being tested
- AI-assisted EGGIM scoring, Conventional EGGIM scoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted EGGIM scoringDiagnostic test
Endoscopists will evaluate the videos with the assistance of the AI system via EGGIM score.
Conventional EGGIM scoringDiagnostic test
Endoscopists will evaluate the videos without the assistance of the AI system via EGGIM score.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted scoring first group | Experimental | Endoscopists will first evaluate the videos with the assistance of the AI system via EGGIM score, and after the washout period, the videos will be evaluated again without the assistance of the AI system. Receives: Diagnostic Test: AI-assisted EGGIM scoring |
| Conventional scoring first group | Active comparator | Endoscopists will first evaluate the videos without the assistance of the AI system via EGGIM score, and after the washout period, the videos will be evaluated again with the assistance of the AI system. Receives: Diagnostic Test: Conventional EGGIM scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the EGGIM-AI system for improving endoscopists' EGGIM scoring performance
Diagnostic accuracy metrics, including the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity between groups at different study phases.
Measured: Through study completion, an average of 3 months
Secondary outcomes (1)
Performance of EGGIM scoring by endoscopists with varying experience levels
Differences in AUC, sensitivity, and specificity of EGGIM scores between experienced and inexperienced endoscopists within each group at different phases.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Nov 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Intestinal MetaplasiaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208864
- Sponsor's protocol ID
- 2025SDU-QILU-4
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an AI System in Training Endoscopists to Assess Gastric Intestinal Metaplasia Via the EGGIM Score: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07208864
- Acronym / sponsor ID
- 2025SDU-QILU-4
- Conditions
- Gastric Intestinal Metaplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized controlled trial with a crossover design incorporated image-enhanced endoscopy (IEE) videos demonstrating complete standardized examinations of five standard gastric areas (antrum greater curvature, antrum lesser curvature, incisura, corpus lesser curvature, and corpus greater curvature). Endoscopists were stratified by experience level and randomly assigned to either the AI-assisted scoring first group, which performed EGGIM scoring with AI assistance in the initial phase followed by conventional scoring after a washout period, or the conventional scoring first group, which completed the assessments in reverse order. The study primarily evaluated the training efficacy of the EGGIM-AI system for improving endoscopists' EGGIM scoring performance by comparing diagnostic accuracy metrics, including the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity between groups at different study phases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted scoring first group | Experimental | Diagnostic Test: AI-assisted EGGIM scoringEndoscopists will first evaluate the videos with the assistance of the AI system via EGGIM score, and after the washout period, the videos will be evaluated again without the assistance of the AI system. |
| Conventional scoring first group | Active comparator | Diagnostic Test: Conventional EGGIM scoringEndoscopists will first evaluate the videos without the assistance of the AI system via EGGIM score, and after the washout period, the videos will be evaluated again with the assistance of the AI system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Endoscopists who have performed ≥50 image-enhanced endoscopy (IEE) procedures per year and demonstrated competency in performing standardized IEE.
Key exclusion criteria (1 listed)
- Endoscopists who participated in data acquisition or were unblinded to patients' identifiable information and clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted EGGIM scoringEndoscopists will evaluate the videos with the assistance of the AI system via EGGIM score. | Diagnostic test | AI-assisted scoring first group |
| Conventional EGGIM scoringEndoscopists will evaluate the videos without the assistance of the AI system via EGGIM score. | Diagnostic test | Conventional scoring first group |
Primary outcome
Efficacy of the EGGIM-AI system for improving endoscopists' EGGIM scoring performance
Time frame: Through study completion, an average of 3 months
Diagnostic accuracy metrics, including the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity between groups at different study phases.
1 secondary outcome
Performance of EGGIM scoring by endoscopists with varying experience levels
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted EGGIM scoring and Conventional EGGIM scoring in people with Gastric Intestinal Metaplasia, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Li (86+18560086106, qilulizhen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the EGGIM-AI system for improving endoscopists' EGGIM scoring performance (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.