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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
363

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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