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NCT Number: NCT07470827

Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Colorectal Adenoma Adenoma Carcinoma Hyperplastic Polyp Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Non-Adenoma Sessile Serrated Lesion

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Gangnam Severance Hospital

Seoul, Gangnam, 06273, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥19 years) with colorectal endoscopic images showing one lesion.
  • Histopathology confirming the lesion as Adenoma (colorectal cancer, adenoma) or Non-Adenoma (sessile serrated lesion, hyperplastic polyp).

Exclusion criteria

  • Images previously used for training or internal validation of the investigational software.
  • History of colectomy.
  • Diagnosed with inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or neuroendocrine tumor.
  • Poor image quality (blurred, incomplete lesion capture).
  • Images with multiple lesions or fewer than two images per lesion.
  • Determined by the investigator to be inappropriate for inclusion.

Treatment and study plan

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).

Reference standard review

Other

Colorectal endoscopic images are independently reviewed by expert endoscopists and confirmed with histopathology to establish the reference standard.

Primary outcomes

  1. Clinical Sensitivity in classifying colorectal lesions (%)

    Time frame: 6 months

    The probability of being classified as "Adenoma" among colorectal endoscopic images confirmed as "Adenoma" through histopathology.

  2. Clinical Specificity in classifying colorectal lesions (%)

    Time frame: 6 months

    The probability of being classified as "Non-Adenoma" among colorectal endoscopic images confirmed as "Non-Adenoma" through histopathology.

Secondary outcomes

  1. Diagnostic Accuracy in classifying colorectal lesions (%)

    Time frame: 6 months

    The overall probability of correctly classifying colorectal lesions as either "Adenoma" or "Non-Adenoma" compared with histopathology.

Sponsors and collaborators

Lead sponsor

WAYCEN Inc

Industry

Registry information

Official study title

The Effectiveness of the Computer-aided Detection/Diagnosis Software, 'WAYMED Endo CL CS', Which Assists Medical Specialists by Automatically Analyzing Colorectal Endoscopic Images With Confirmed Adenoma or Non-Adenoma Lesions, Detecting the Lesion, and Providing Probabilities as to Whether the Lesion Belongs to the Adenoma or Non-Adenoma Group: A Single-center, Single Arm, Retrospective, Superiority, Single-blind, and Pivotal Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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