CompletedNot Applicable

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

South Korea653 participantsStarted 2023-08-22

Plain-language 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).

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Absence of pathological results for the lesion
✕. History of gastrectomy
✕. Judged as inappropriate for inclusion by the investigator

What they're measuring

Clinical Sensitivity in classifying early gastric cancer (EGC) based on the depth of invasion (%)

Timeframe: 3 months

Clinical Specificity in classifying early gastric cancer (EGC) based on the depth of invasion (%)

Timeframe: 3 months

Trial details

NCT IDNCT06317103

SponsorWAYCEN Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-08-22

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