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

March 9, 2026 updated by: WAYCEN Inc

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Gangnam
      • Seoul, Gangnam, South Korea, 06273
        • Yonsei University Gangnam Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Colorectal endoscopic images from adult patients (≥19 years) who underwent colonoscopy and biopsy, with confirmed histopathology results for Adenoma or Non-Adenoma lesions.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: WAYMED endo CL CS
Classification of colorectal endoscopic images as "Adenoma" or "Non-Adenoma" by WAYMED endo CL CS (Computer-aided diagnosis software for colorectal endoscopy).
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.
Other: Reference standard review
Colorectal endoscopic images are independently reviewed by expert endoscopists and confirmed with histopathology to establish the reference standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WAYCEN Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WAY-CTP-WME02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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