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ClinicalTrials.gov ID

NCT07362524

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

363Estimated

Last Update Posted

Jan 23, 2026Actual

Start Date

Feb 15, 2026Estimated

Primary Completion Date

Nov 15, 2026Estimated

Completion Date

Nov 15, 2026Estimated

Official Title

Artificial Intelligence-assisted Optical Diagnosis for the Resect-and-discard Strategy in Clinical Practice in Non-academic Hospitals: a Randomized Controlled Study

Brief Summary

To validate the feasibility of promoting colorectal diminutive polyp "predict, resect, and discard" and "diagnose and leave" strategies for non-experts in general hospitals through CADx system.

Detailed Description

This study will: (1) develop and refine a deep learning model for optical diagnosis of diminutive colorectal polyps-predicting histologic type and the presence of advanced adenoma components-based on multicenter endoscopic videos; (2) conduct a randomized controlled study recruiting endoscopists from different regions and experience levels nationwide to evaluate, with or without access to the model's diagnostic output, the success rates of implementing the "resect and discard" and "diagnose and leave" strategies as well as identifying advanced adenoma components; and (3) carry out a prospective randomized controlled trial to assess the benefits of a real-time AI-assisted endoscopic system in facilitating endoscopists' implementation of the "resect and discard" and "diagnose and leave" strategies for diminutive colorectal polyps.

• Colorectal Polyps

• AI-Assisted Real-time Endoscopic Diagnosis System

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Agree to participate in this prospective randomized controlled study;
2. Age ≥18 years for colonoscopy;
3. At least one colorectal diminutive polyp (size <=5mm) found during examination;

Exclusion Criteria:

1. Already participating in other clinical trials, having signed informed consent and being in the follow-up period of other clinical trials;
2. Already participating in drug clinical trials and being in the washout period of experimental or control drugs;
3. History of drug or alcohol abuse or psychological disorders in the past five years;
4. Pregnant or lactating patients;
5. Known polyposis syndromes;
6. Patients with gastrointestinal bleeding;
7. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
8. Patients with contraindications to tissue biopsy;
9. Previous history of allergic reactions to bowel cleansing agent components;
10. Suffering from intestinal obstruction or perforation, toxic megacolon, heart failure (Grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, etc.;
11. Patient's bowel preparation BBPS score <6 for this colonoscopy;
12. Researchers consider the patient unsuitable for trial participation.

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

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