Colorectal AdenomaNCT07470827
Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions
An observational study of Colorectal Adenoma and Sessile Serrated Lesion, run by WAYCEN Inc at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Adenoma, Sessile Serrated Lesion, Hyperplastic Polyp
- What is being tested?
- WAYMED endo CL CS and Reference standard review
- Type of treatment
- Medical device
- How many people
- 1,178 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Gangnam Severance Hospital
Seoul, Gangnam, 06273
About this study
Official 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
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.
Read the 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.
- Conditions
- Colorectal Adenoma, Sessile Serrated Lesion, Hyperplastic Polyp, Carcinoma, Adenoma, Non-Adenoma
- Being tested
- WAYMED endo CL CS, Reference standard review
- Keywords
- Colorectal Endoscopy, Adenoma, Non-Adenoma, Artificial Intelligence, Computer-Aided Diagnosis (CADx), Colorectal Cancer Screening
- Medical subject headings
- Carcinoma, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAYMED endo CL CSDevice
Classification of colorectal endoscopic images as "Adenoma" or "Non-Adenoma" by WAYMED endo CL CS (Computer-aided diagnosis software for colorectal endoscopy).
Reference standard reviewOther
Colorectal endoscopic images are independently reviewed by expert endoscopists and confirmed with histopathology to establish the reference standard.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: WAYMED endo CL CS | |
| 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. Receives: Other: Reference standard review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Sensitivity in classifying colorectal lesions (%)
The probability of being classified as "Adenoma" among colorectal endoscopic images confirmed as "Adenoma" through histopathology.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Diagnostic Accuracy in classifying colorectal lesions (%)
The overall probability of correctly classifying colorectal lesions as either "Adenoma" or "Non-Adenoma" compared with histopathology.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Sep 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WAYCEN Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470827
- Sponsor's protocol ID
- WAY-CTP-WME02
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07470827
- Acronym / sponsor ID
- WAY-CTP-WME02
- Conditions
- Colorectal Adenoma, Sessile Serrated Lesion, Hyperplastic Polyp, Carcinoma, Adenoma, Non-Adenoma
- Keywords
- Colorectal Endoscopy, Adenoma, Non-Adenoma, Artificial Intelligence, Computer-Aided Diagnosis (CADx), Colorectal Cancer Screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,178 participants (estimated)
- Lead sponsor
- WAYCEN IncIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | – | Device: WAYMED endo CL CSColorectal 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 | – | Other: Reference standard reviewAll 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAYMED endo CL CSClassification of colorectal endoscopic images as "Adenoma" or "Non-Adenoma" by WAYMED endo CL CS (Computer-aided diagnosis software for colorectal endoscopy). | Device | Trial group |
| Reference standard reviewColorectal endoscopic images are independently reviewed by expert endoscopists and confirmed with histopathology to establish the reference standard. | Other | Reference Standard |
Primary outcome
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.
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.
1 secondary outcome
Diagnostic Accuracy in classifying colorectal lesions (%)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenoma and Sessile Serrated Lesion, run by WAYCEN Inc at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Sensitivity in classifying colorectal lesions (%) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.