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EndocytoscopyNCT06982885

Clinical Study on the Diagnosis of Colorectal Lesions by Real-time Artificial Intelligence Assisted Endocytoscopy Combined With Narrow Band Imaging

An observational study of Endocytoscopy, run by The First Hospital of Jilin University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Colorectal cancer (colorectal cancer, CRC) is the third most common malignant tumor globally and the second leading cause of cancer-related deaths. Colonoscopy is considered the preferred method for screening colorectal cancer; early detection and removal of colorectal neoplasms can significantly reduce the incidence… Read more about this study

Who is it for?
Any age
Conditions the study is for
Endocytoscopy
What is being tested?
artificial intelligence
How many people
500 participants
Where
1 siteChina
Study dates
19 May 2025to 31 Dec 2025
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: patients with colorectal lesions

Who may be able to join

  • colorectal lesions

Who cannot join

  • lesions lacking high-quality images;
  • Inflammatory bowel disease, familial adenomatous polyposis and other special diseases;
  • submucosal tumors;
  • Pathological diagnosis of Peutz-Jeghers polyps, juvenile polyps, lymphoma and other pathological types.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • First Hospital of Jilin University

    Changchun, Jilin, 130021

    Mingqing Liu, +8613204300453, liumq23@jlu.edu.cn

    Recruiting

Other trials in China

About this study

Colorectal cancer (colorectal cancer, CRC) is the third most common malignant tumor globally and the second leading cause of cancer-related deaths. Colonoscopy is considered the preferred method for screening colorectal cancer; early detection and removal of colorectal neoplasms can significantly reduce the incidence and mortality of colorectal cancer. To improve the diagnostic accuracy of endoscopy in colorectal lesions, many endoscopic techniques have been applied clinically, such as image-enhanced endoscopy, including narrow band imaging (narrow-band imaging, NBI), magnifying endoscopy, chromoendoscopy, confocal laser endoscopy, and endocytoscopy (EC). However, with the increasing number of endoscopic resections, the costs associated with the pathological diagnosis of resected specimens have risen year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to differentiate the nature of lesions during colonoscopy.

Endocytoscopy is an ultra-high magnification endoscope that, when combined with chemical staining and narrowband imaging techniques, allows the endoscopist to observe the nuclear morphology of colorectal lesions, the shape of glands, and the morphology of microvessels through the naked eye. This approach avoids the need for pathological examination, achieving the goal of real-time biopsy in vivo. However, the accuracy of endocytoscopic image interpretation requires extensive experience to improve judgment, and there is a certain degree of subjectivity and error in the endoscopist's assessment process. Therefore, to address this issue, clinical applications have proposed using artificial intelligence (AI) for computer-aided diagnosis. The investigator's center has previously developed an AI-assisted diagnostic system based on endocytoscopy with NBI to assist in determining the nature of colorectal lesions. However, forward-looking clinical studies are still lacking to verify the effectiveness of this AI-assisted system. Thus, the investigator aim to conduct such clinical research to validate the clinical efficacy of this AI.

Conditions
Endocytoscopy
Being tested
artificial intelligence
Keywords
endocytoscopy, artificial intelligence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • artificial intelligenceDiagnostic test

    Artificial intelligence assisted diagnostic system was used to diagnose colorectal lesions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The accuracy of AI in diagnosing tumor lesions (including sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV)) and high confidence rate were evaluated

    Measured: 2025-12-31

Secondary outcomes (6)
  1. The accuracy and high confidence rate of AI in diagnosing non-neoplastic lesions, adenomas and invasive cancers were evaluated

    Measured: 2025-12-31

  2. The accuracy and high confidence rate of AI diagnosis of rectosigmoid adenomas ≤5 mm were evaluated

    Measured: 2025-12-31

  3. The influence of lesion location, size and shape on artificial intelligence diagnosis of lesion nature was evaluated.

    Measured: 2025-12-31

  4. The accuracy and high confidence rate of artificial intelligence, endoscopists and endoscopists combined with artificial intelligence in diagnosing lesion nature were compared

    Measured: 2025-12-31

  5. Compare the time it takes for an endoscopist and an AI to make a diagnosis

    Measured: 2025-12-31

  6. To compare whether the diagnostic efficacy of the intracellular endoscopic AI-assisted diagnosis system for diagnosing colorectal neoplastic lesions is not inferior to that of the EndoBRAIN-NBI model.

    Measured: 2025-12-31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study start19 May 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06982885
Sponsor's protocol ID
25K190-001
Status last verified
Aug 2025
First submitted
14 May 2025
Last updated
7 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endocytoscopy, run by The First Hospital of Jilin University at 1 site in China.

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 1 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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 China. 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?

Contact Mingqing Liu (15043076005, liumq23@mails.jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The accuracy of AI in diagnosing tumor lesions (including sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV)) and high confidence rate were evaluated (time frame: 2025-12-31). 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 7 Aug 2025.

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