Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group (the endoscopists) | Other | — | UNRESOLVED |
| WADYMED endo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Trial group
- description
- The gastro-endoscopic images in this group are classified as "Mucosa" or "Submucosa" by WADYMED endo.
- interventionNames
- Device: WADYMED endo
- label
- Control group
- description
- The gastro-endoscopic images in this group are interpreted as "Mucosa" or "Submucosa" by the endoscopists.
- interventionNames
- Other: Control group (the endoscopists)
Primary outcomes (2)
- measure
- Clinical Sensitivity in classifying early gastric cancer (EGC) based on the depth of invasion (%)
- timeFrame
- 3 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria:
1\. 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
1. M ("Mucosa (mucosal invasion)"): Medical data of early gastric cancer patients with confirmed "Mucosa" for the depth of invasion category in the EMR.
2. SM ("Submucosa (submucosal invasion)"): Medical data of early gastric cancer patients with confirmed "Submucosa" for the depth of invasion category in the EMR.
Exclusion Criteria:
1. Absence of pathological results for the lesion
2. History of gastrectomy
3. Judged as inappropriate for inclusion by the investigatorReferences
Publications (0)
Data not yet available