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

Completed

• Conditions: Early Gastric Cancer
• Interventions: Device: WADYMED endo; Other: Control group (the endoscopists)

• Registration Number: NCT06317103
• Lead Sponsor: WAYCEN Inc

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).

Detailed Description

This clinical trial aims to evaluate the sensitivity and specificity of 'WAYMED endo' compared to that of endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images. It is designed as a retrospective, single-center, double-arm, double-blind (endoscopist, investigational medical device applicator), controlled, and pivotal trial. Medical data collected retrospectively from subjects who underwent Esophagogastroduodenoscopy (EGD) and biopsy are screened. As a result of screening, medical data that meet all inclusion/exclusion criteria are enrolled and assigned to the trial and control groups.

In the trial group, the investigational medical device is applied to the images, while the endoscopists interpret the images in the control group. The Reference Standard Establishment Committee records the reference standard results as either "Mucosa (mucosal invasion)" or "Submucosa (submucosal invasion)", based on the depth of invasion of the lesion, and marks the detected lesion area with an oval on the image. The reference standard results are blinded, so they cannot be disclosed to the endoscopists or the investigational medical device applicator.

The primary endpoint includes the sensitivity (%) and specificity (%) of "WAYMED endo" and the endoscopists in classifying EGC based on the depth of invasion categories ("Mucosa" or "Submucosa") as confirmed by the reference standard. The secondary endpoint includes the accuracy (%) of "WAYMED endo" and the endoscopists in accurately classifying all early gastric cancer images as either "Mucosa" or "Submucosa", based on the depth of invasion categories as confirmed through pathological examination.

Study Timeline

• Study Start: 2023-08-22
• Primary Completion: 2023-08-22
• Study Completion: 2023-08-22
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 653

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

2. M ("Mucosa (mucosal invasion)"): Medical data of early gastric cancer patients with confirmed "Mucosa" for the depth of invasion category in the EMR.

3. 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 investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trial group	WADYMED endo	The gastro-endoscopic images in this group are classified as "Mucosa" or "Submucosa" by WADYMED endo.
Control group	Control group (the endoscopists)	The gastro-endoscopic images in this group are interpreted as "Mucosa" or "Submucosa" by the endoscopists.

Primary Outcome Measures

Name	Time	Method
Clinical Sensitivity in classifying early gastric cancer (EGC) based on the depth of invasion (%)	3 months	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.
Clinical Specificity in classifying early gastric cancer (EGC) based on the depth of invasion (%)	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy in classifying the depth of invasion categories ("Mucosa" or "Submucosa") for early gastric cancer (%)	3 months	The probability of accurately classifying all early gastric cancer images as either "Mucosa" or "Submucosa", based on the depth of invasion categories confirmed through pathological examination.

Trial Locations

Locations (1)

Yonsei University Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of