AI-Assisted Real-Time Endoscopic Characterization of Diminutive Colorectal Polyps in Non-Academic Hospitals

January 15, 2026 updated by: Xiaobo Li, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

363

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 200127
      • Wuxi, Jiangsu, China
        • Wuxi Ninth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CADx assisted colonoscopy group
Device: AI-Assisted Real-time Endoscopic Diagnosis System
CADx assists endoscopists in diagnosing colorectal diminutive polyps (<=5cm) during colonoscopy using narrow-band imaging (NBI). The system provides real-time prediction values of NICE classification for colorectal polyp. The intervention group receives AI-assisted diagnostic information displayed
No Intervention: Routine colonoscopy group
Endoscopists perform standard endoscopic diagnosis using conventional NBI-based NICE classification without AI assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines
Time Frame: 14 days
The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the U.S. 2020 USMSTF consensus for post-polypectomy surveillance.
14 days
Negative Predictive Value for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Confidence
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to according to European Guidelines
Time Frame: 14 days
The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the European ESGE 2020 consensus for post-polypectomy surveillance.
14 days
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Asia-Pacific Guidelines
Time Frame: 14 days
The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the Asia-Pacific APWG 2022 consensus for post-polypectomy surveillance.
14 days
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Expert Consensus on Outpatient Management of Colorectal Polyps
Time Frame: 14 days
The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the Expert Consensus on Outpatient Management of Colorectal Polyps (2025, Chengdu).
14 days
Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Diagnostic Confidence
Time Frame: 30 days
30 days
Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Diminutive Polyps under High Diagnostic Confidence
Time Frame: 14 days
14 days
Diagnostic Accuracy of Endoscopists in Characterizing Colorectal Diminutive Polyps when assessed with High Diagnostic Confidence.
Time Frame: 14 days
14 days
Improvement in Endoscopists' Diagnostic Confidence with AI Assistance
Time Frame: 14 days
14 days
Improvement in Endoscopists' Diagnostic Accuracy in Characterizing Colorectal Diminutive Polyps with AI Assistance.
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

September 27, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • KY2024-080-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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