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Single-center, Randomized, Superiority Pivotal Clinical Study to Evaluate the Efficacy of Artificial Intelligence-based Upper Gastrointestinal Endoscopy Image

Single-center, Single Group, Randomized, Superiority Pivotal Clinical Study to Evaluate the Efficacy and Safety of Artificial Intelligence-based Upper Gastrointestinal Endoscopy Image Diagnosis Aid Software

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06969794
Enrollment
3385
Registered
2025-05-14
Start date
2023-07-01
Completion date
2023-08-17
Last updated
2025-05-14

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

Conditions

Artificial Intelligence, Gastric Lesion, Gastric Neoplasm

Brief summary

We will conduct a single-center retrospective study at a university hospital. A total of 3,385 gastroscopic white-light images from patients with pathologically confirmed findings will be analyzed. The AI software will automatically identify images as non-neoplastic or neoplastic (low-grade dysplasia, high-grade dysplasia, early gastric cancer with mucosal or submucosal invasion, or advanced gastric cancer) and highlighted lesion locations. Two experienced endoscopists will independently review the same image set without AI assistance for comparison. Primary outcomes are sensitivity and specificity of the AI in detecting gastric neoplasms (by category and overall), and the localization accuracy measured by the localization receiver operating characteristic (LROC) curve area. Secondary outcomes is includes comparison of the AI's diagnostic performance with that of endoscopists.

Detailed description

We will conduct a single-center retrospective study at a university hospital. A total of 3,385 gastroscopic white-light images from patients with pathologically confirmed findings will be analyzed. The AI software will automatically identify images as non-neoplastic or neoplastic (low-grade dysplasia, high-grade dysplasia, early gastric cancer with mucosal or submucosal invasion, or advanced gastric cancer) and highlighted lesion locations. Two experienced endoscopists will independently review the same image set without AI assistance for comparison. Primary outcomes are sensitivity and specificity of the AI in detecting gastric neoplasms (by category and overall), and the localization accuracy measured by the localization receiver operating characteristic (LROC) curve area. Secondary outcomes is includes comparison of the AI's diagnostic performance with that of endoscopists. Inclusion criteria: Age 19 or older At least one gastric lesion biopsied with a definitive pathological diagnosis Availability of high-quality white-light endoscopy images of the lesion and surrounding mucosa Exclusion criteria: Poor-quality images (e.g., out of focus or obscured) Lack of histopathological confirmation of the lesion Each image will be paired with a reference standard diagnosis based on the pathology result for that lesion or region.

Interventions

None listed

Sponsors

Chuncheon Sacred Heart Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Age 19 or older * At least one gastric lesion biopsied with a definitive pathological diagnosis * Availability of high-quality white-light endoscopy images of the lesion and surrounding mucosa

Exclusion criteria

* Poor-quality images (e.g., out of focus or obscured) * Lack of histopathological confirmation of the lesion

Design outcomes

Primary

MeasureTime frameDescription
AI performanceDay 1sensitivity and specificity of the AI in detecting gastric neoplasms (by category and overall), and the localization accuracy measured by the localization receiver operating characteristic (LROC) curve area.

Secondary

MeasureTime frameDescription
comparison of the AI's diagnostic performance with that of endoscopists.Day 1Secondary outcomes included comparison of the AI's diagnostic performance with that of endoscopists. (sensitivity and specificity of the AI in detecting gastric neoplasms (by category and overall), and the localization accuracy measured by the localization receiver operating characteristic (LROC) curve area.)

Countries

South Korea

Outcome results

None listed

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