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The purpose of this clinical trial is to evaluate the effectiveness of the computer-aided diagnosis (CADx) software, 'WAYMED endo CL CS', which assists medical specialists by automatically analyzing colorectal endoscopic images, identifying lesions, and providing probability values to classify them as Adenoma or Non-Adenoma. This pivotal trial is designed to confirm that 'WAYMED endo CL CS' can support clinicians in diagnostic decision-making by improving the classification of colorectal lesions.
This clinical trial aims to assess the clinical sensitivity and specificity of 'WAYMED endo CL CS' in detecting colorectal lesions and classifying them into Adenoma (colorectal cancer, adenoma) or Non-Adenoma(Hyperplastics, etc) groups. The trial is designed as a retrospective, single-center, single-arm, single-blind, superiority, and pivotal study.
Colorectal endoscopic images and corresponding histopathology results are retrospectively collected from adult patients. Images meeting all inclusion/exclusion criteria are enrolled. Each lesion is annotated and verified by a Reference Standard Establishment Committee, which consists of experienced endoscopy specialists. The investigational software is applied to the enrolled images to automatically detect and classify the lesions, while the reference standard serves as the comparator.
The primary endpoints include clinical sensitivity (%) and specificity (%) of 'WAYMED endo CL CS' in distinguishing Adenoma from Non-Adenoma lesions. The secondary endpoint is the overall diagnostic accuracy (%).
This study is intended to provide confirmatory clinical evidence required for regulatory approval of 'WAYMED endo CL CS' as a computer-aided diagnosis (CADx) software for colorectal endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial group | Colorectal endoscopic images in this group are analyzed by WAYMED endo CL CS, which identifies lesions and classifies them as "Adenoma" or "Non-Adenoma" with probability values. |
| |
| Reference Standard | All lesions are verified by histopathology and annotated by the Reference Standard Establishment Committee (experienced endoscopy specialists). This serves as the comparator for evaluating diagnostic performance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WAYMED endo CL CS | Device | Classification of colorectal endoscopic images as "Adenoma" or "Non-Adenoma" by WAYMED endo CL CS (Computer-aided diagnosis software for colorectal endoscopy). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Sensitivity in classifying colorectal lesions (%) | The probability of being classified as "Adenoma" among colorectal endoscopic images confirmed as "Adenoma" through histopathology. | 6 months |
| Clinical Specificity in classifying colorectal lesions (%) | The probability of being classified as "Non-Adenoma" among colorectal endoscopic images confirmed as "Non-Adenoma" through histopathology. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy in classifying colorectal lesions (%) | The overall probability of correctly classifying colorectal lesions as either "Adenoma" or "Non-Adenoma" compared with histopathology. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Colorectal endoscopic images from adult patients (≥19 years) who underwent colonoscopy and biopsy, with confirmed histopathology results for Adenoma or Non-Adenoma lesions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Gangnam Severance Hospital | Seoul | Gangnam | 06273 | South Korea |
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| Reference standard review | Other | Colorectal endoscopic images are independently reviewed by expert endoscopists and confirmed with histopathology to establish the reference standard. |
|
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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