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
NCT ID: NCT06317103
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
653 participants
OBSERVATIONAL
2023-08-22
2023-08-22
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Trial group
The gastro-endoscopic images in this group are classified as "Mucosa" or "Submucosa" by WADYMED endo.
WADYMED endo
Classification of the gastro-endoscopic images as "Mucosa" or "Submucosa" by WADYMED endo (Gastric cancer image, computer aided detection/diagnosis software)
Control group
The gastro-endoscopic images in this group are interpreted as "Mucosa" or "Submucosa" by the endoscopists.
Control group (the endoscopists)
Interpretation of the gastro-endoscopic images as "Mucosa" or "Submucosa" by the endoscopists
Interventions
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WADYMED endo
Classification of the gastro-endoscopic images as "Mucosa" or "Submucosa" by WADYMED endo (Gastric cancer image, computer aided detection/diagnosis software)
Control group (the endoscopists)
Interpretation of the gastro-endoscopic images as "Mucosa" or "Submucosa" by the endoscopists
Eligibility Criteria
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Inclusion Criteria
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
2. History of gastrectomy
3. Judged as inappropriate for inclusion by the investigator
19 Years
ALL
No
Sponsors
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WAYCEN Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jie-Hyun Kim
Role: PRINCIPAL_INVESTIGATOR
Yonsei University Gangnam Severance Hospital
Locations
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Yonsei University Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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WAY-CTP-WME01-MSM
Identifier Type: -
Identifier Source: org_study_id
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