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
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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