Colorectal NeoplasmsNCT07744607
Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial Intelligence-based Medical Device Software Endoscopic Imaging Assistance
An observational study of Colorectal Neoplasms and Colonic Polyps, run by Ainex Corporation at 1 site in South Korea.
Trial summary
This completed retrospective study evaluated the clinical performance of ENAD-CADx-01, an artificial intelligence-based medical device software intended to assist healthcare professionals in characterizing colorectal lesions in colonoscopy images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colonic Polyps, Hyperplastic Polyps
- How many people
- 1,114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2025to 17 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults aged 18 years or older who underwent colonoscopy at Asan Medical Center and had previously collected colonoscopy images of colorectal lesions with corresponding histopathological results. Eligible images were retrospectively analyzed to evaluate the clinical performance of ENAD-CADx-01 in classifying lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion.
Who may be able to join
- Participants aged 18 years or older at the time of colonoscopy.
- Participants who underwent colonoscopy at Asan Medical Center and had colorectal lesion images available for retrospective analysis.
- Participants with corresponding histopathological results available as the reference standard.
- Colonoscopy images that met the predefined image quality requirements for analysis by ENAD-CADx-01.
Who cannot join
- Participants without corresponding histopathological results for the colorectal lesion.
- Images with insufficient quality for analysis, including severe blur, obstruction, or inadequate visualization of the lesion.
- Images or records with missing or insufficient data required for the clinical performance analysis.
- Lesions that did not meet the predefined target lesion categories or other eligibility requirements specified in the clinical investigation plan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial Intelligence-Based Medical Device Software for Endoscopic Imaging Assistance: A Single-Center, Single-Arm, Retrospective, Confirmatory Clinical Trial
This completed retrospective study evaluated the clinical performance of ENAD-CADx-01, an artificial intelligence-based medical device software intended to assist healthcare professionals in characterizing colorectal lesions in colonoscopy images. Previously collected colonoscopy images and corresponding histopathological results from Asan Medical Center were analyzed. The performance of ENAD-CADx-01 was evaluated based on its sensitivity, specificity, and overall accuracy in classifying colorectal lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion. No participants were prospectively enrolled, and no study-related intervention was performed.
- Keywords
- Computer-Aided Diagnosis, Artificial Intelligence, Colonoscopy, Colorectal Lesion Characterization, Medical Device Software
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Sensitivity for Neoplasm
Measured: Up to 4 weeks
Clinical Specificity for Neoplasm
Measured: Up to 4 weeks
Clinical Sensitivity for Hyperplastic Polyps
Measured: Up to 4 weeks
Clinical Specificity for Hyperplastic Polyps
Measured: Up to 4 weeks
Clinical Sensitivity for Sessile Serrated Lesions
Measured: Up to 4 weeks
Clinical Specificity for Sessile Serrated Lesions
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start20 Jan 2025
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 1,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ainex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744607
- Sponsor's protocol ID
- Ainex-CRC-01
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial Intelligence-Based Medical Device Software for Endoscopic Imaging Assistance: A Single-Center, Single-Arm, Retrospective, Confirmatory Clinical Trial
- ClinicalTrials.gov ID
- NCT07744607
- Acronym / sponsor ID
- Ainex-CRC-01
- Keywords
- Computer-Aided Diagnosis, Artificial Intelligence, Colonoscopy, Colorectal Lesion Characterization, Medical Device Software
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Ainex CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 4 Aug 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.
This completed retrospective study evaluated the clinical performance of ENAD-CADx-01, an artificial intelligence-based medical device software intended to assist healthcare professionals in characterizing colorectal lesions in colonoscopy images. Previously collected colonoscopy images and corresponding histopathological results from Asan Medical Center were analyzed. The performance of ENAD-CADx-01 was evaluated based on its sensitivity, specificity, and overall accuracy in classifying colorectal lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion. No participants were prospectively enrolled, and no study-related intervention was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults aged 18 years or older who underwent colonoscopy at Asan Medical Center and had previously collected colonoscopy images of colorectal lesions with corresponding histopathological results. Eligible images were retrospectively analyzed to evaluate the clinical performance of ENAD-CADx-01 in classifying lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion.
Key inclusion criteria (4 listed)
- Participants aged 18 years or older at the time of colonoscopy.
- Participants who underwent colonoscopy at Asan Medical Center and had colorectal lesion images available for retrospective analysis.
- Participants with corresponding histopathological results available as the reference standard.
- Colonoscopy images that met the predefined image quality requirements for analysis by ENAD-CADx-01.
Key exclusion criteria (4 listed)
- Participants without corresponding histopathological results for the colorectal lesion.
- Images with insufficient quality for analysis, including severe blur, obstruction, or inadequate visualization of the lesion.
- Images or records with missing or insufficient data required for the clinical performance analysis.
- Lesions that did not meet the predefined target lesion categories or other eligibility requirements specified in the clinical investigation plan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Sensitivity for Neoplasm
Time frame: Up to 4 weeks
Clinical Specificity for Neoplasm
Time frame: Up to 4 weeks
Clinical Sensitivity for Hyperplastic Polyps
Time frame: Up to 4 weeks
Clinical Specificity for Hyperplastic Polyps
Time frame: Up to 4 weeks
Clinical Sensitivity for Sessile Serrated Lesions
Time frame: Up to 4 weeks
Clinical Specificity for Sessile Serrated Lesions
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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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 Neoplasms and Colonic Polyps, run by Ainex Corporation 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 for Neoplasm (time frame: Up to 4 weeks). The study lists 6 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 4 Aug 2026.