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

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06317103
• Other study ID #: WAY-CTP-WME01-MSM
• Status: Completed
• Start date: August 22, 2023
• Est. completion date: August 22, 2023

Study information

• Verified date: March 2024
• Source: WAYCEN Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 653
• Est. completion date: August 22, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 investigator

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
WAYCEN Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Accuracy in classifying the depth of invasion categories ("Mucosa" or "Submucosa") for early gastric cancer (%)	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.	3 months