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
A Retrospective, Single Center, Double Arm, Blind, Controlled, Pivotal Trial to Evaluate Classification by the Depth of Invasion of Early Gastric Cancer Sensitivity and Specificity of Gastric Cancer Image Computer Aided Detection and Diagnosis Software 'WAYMED Endo' and Endoscopists in Endoscopic Images
1 other identifier
observational
653
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2023
CompletedFirst Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 19, 2024
CompletedMarch 19, 2024
March 1, 2024
Same day
March 5, 2024
March 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Sensitivity in classifying early gastric cancer (EGC) based on the depth of invasion (%)
The probability of being classified as "Mucosa (mucosal invasion)", based on the depth of invasion categories for early gastric cancer, among gastro-endoscopic images confirmed as "Mucosa" through the results of pathologic examination.
3 months
Clinical Specificity in classifying early gastric cancer (EGC) based on the depth of invasion (%)
The probability of being classified as "Submucosa (submucosal invasion)", based on the depth of invasion categories for early gastric cancer, among gastro-endoscopic images confirmed as "Submucosa" through the results of pathologic examination.
3 months
Secondary Outcomes (1)
Accuracy in classifying the depth of invasion categories ("Mucosa" or "Submucosa") for early gastric cancer (%)
3 months
Study Arms (2)
Trial group
The gastro-endoscopic images in this group are classified as "Mucosa" or "Submucosa" by WADYMED endo.
Control group
The gastro-endoscopic images in this group are interpreted as "Mucosa" or "Submucosa" by the endoscopists.
Interventions
Classification of the gastro-endoscopic images as "Mucosa" or "Submucosa" by WADYMED endo (Gastric cancer image, computer aided detection/diagnosis software)
Interpretation of the gastro-endoscopic images as "Mucosa" or "Submucosa" by the endoscopists
Eligibility Criteria
Gastro-endoscopic images of early gastric cancer patients who underwent EGD
You may qualify if:
- \. Patients aged 19 years or older who underwent EGD 2. Confirmed the presence of gastric cancer through the Electronic Medical Record (EMR), including reports of EGD or pathology
- M ("Mucosa (mucosal invasion)"): Medical data of early gastric cancer patients with confirmed "Mucosa" for the depth of invasion category in the EMR.
- SM ("Submucosa (submucosal invasion)"): Medical data of early gastric cancer patients with confirmed "Submucosa" for the depth of invasion category in the EMR.
You may not qualify if:
- Absence of pathological results for the lesion
- History of gastrectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- WAYCEN Inclead
Study Sites (1)
Yonsei University Gangnam Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie-Hyun Kim
Yonsei University Gangnam Severance Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 19, 2024
Study Start
August 22, 2023
Primary Completion
August 22, 2023
Study Completion
August 22, 2023
Last Updated
March 19, 2024
Record last verified: 2024-03