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Application Evaluation Research on the Artificial Intelligence-assisted Support System for the Diagnosis of Colorectal Tubular Adenoma Lesions

Application Evaluation Research on the Artificial Intelligence-assisted Support System for the Diagnosis of Colorectal Tubular Adenoma Lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07073430
Enrollment
4000
Registered
2025-07-18
Start date
2023-11-28
Completion date
2026-10-31
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence (AI), Colorectal Adenoma

Brief summary

This study is a prospective,multi-center and observational clinical study.Investigators would like to innovatively construct a "trinity" database of colorectal tubular adenomas based on white light - magnifying chromo - pathological images.It simulates the decision - making logic of doctors, and based on the multimodal endoscopic LAFEQ method previously proposed, develop a multimodal deep - learning diagnostic model for colon adenomas and an interpretable risk prediction model for intestinal adenomas. While achieving high - precision auxiliary treatment decisions, clearly present the decision - making basis, and break through the limitation of poor interpretability of previous medical imaging AI models.

Interventions

DEVICEAI models with NBI

AI models for detecting intestinal adenoma in magnifying endoscopy with NBI.

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER
Beijing Friendship Hospital, Captial Medical University
CollaboratorUNKNOWN
Air Force Military Medical University, China
CollaboratorOTHER
The Sixth Affiliated Hospital, Sun Yat-sen University
CollaboratorUNKNOWN
Army Medical University, China
CollaboratorOTHER
Guizhou Provincial People's Hospital
CollaboratorOTHER
Shengjing Hospital
CollaboratorOTHER
The Second Medical Center, Chinese PLA General Hospital
CollaboratorUNKNOWN
Zhejiang University
CollaboratorOTHER
Shandong University
CollaboratorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged ≥ 18 years, who need to undergo colonoscopy, regardless of gender. * Voluntarily sign the informed consent form * Promise to abide by the research procedures and cooperate in the implementation of the entire research process.

Exclusion criteria

* Patients who has a history of abdominal or pelvic surgery or radiotherapy in the past; * Patients who has definite active lower gastrointestinal bleeding. * Existing or suspected hereditary colorectal polyposis, inflammatory bowel disease; * Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg after standardized treatment) * There is a history of stroke, coronary artery disease, or vascular disease; * Pregnant; * Intestinal preparation cannot be carried out.

Design outcomes

Primary

MeasureTime frameDescription
The accuracy rate of diagnosing adenomasduring endoscopyThe prediction rate of the interpretable artificial intelligence-assisted diagnosis model for the disease risk level.

Secondary

MeasureTime frameDescription
The prediction for the disease risk levelduring endoscopyThe prediction rate of the interpretable artificial intelligence-assisted diagnosis model for the disease risk level.

Countries

China

Contacts

CONTACTMingkai Chen
kaimingchen@163.com13720330580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026