A Clinical Trial to Evaluate the Sensitivity and Specificity of "WAYMED Endo" Compared to the Endoscopists in Classifying Early Gastric Cancer (EGC) Based on the Depth of Invasion in Endoscopic Images

NCT06317103 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 653

Last updated 2024-03-19

No results posted yet for this study

Summary

The purpose of this clinical trial is to prove that the prediction capability of 'WAYMED endo' is superior to that of the endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images.

The computer-aided detection·diagnosis software is an Artificial Intelligence (AI) software used to assist medical specialists in diagnostic decisions by automatically classifying EGC based on the depth of invasion categories in gastro-endoscopic images and displaying the results and possibilities on the User Interface (UI).

Conditions

  • Early Gastric Cancer

Interventions

DEVICE

WADYMED endo

Classification of the gastro-endoscopic images as "Mucosa" or "Submucosa" by WADYMED endo (Gastric cancer image, computer aided detection/diagnosis software)

OTHER

Control group (the endoscopists)

Interpretation of the gastro-endoscopic images as "Mucosa" or "Submucosa" by the endoscopists

Sponsors & Collaborators

  • WAYCEN Inc

    lead INDUSTRY

Principal Investigators

  • Jie-Hyun Kim · Yonsei University Gangnam Severance Hospital

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2023-08-22
Completion
2023-08-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06317103 on ClinicalTrials.gov