Impact of CADx on Endoscopists' Histologic Characterization of Diminutive Colorectal Polyps

April 12, 2026 updated by: Xiaobo Li, Shanghai Jiao Tong University School of Medicine
This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.

In this randomized controlled trial, endoscopists will be assigned to one of three arms: no CADx assistance, CADx assistance without predicted probability, or CADx assistance with predicted probability. The CADx system provides NICE-based histology predictions (Type 1 vs Type 2), which endoscopists may use to support optical diagnosis and subsequent management decisions, including surveillance interval recommendations when applicable. Outcomes will compare endoscopist-level pass rates and diagnostic performance metrics relevant to PIVI-based adoption, with histopathology as the reference standard where applicable.

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 Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200120
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

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:

  • Endoscopists with NBI experience

Exclusion Criteria:

-Endoscopists without colonoscopy and NBI experience

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
No Intervention: Standard Colonoscopy (No CADx Assistance)
Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) without any CADx assistance.
Experimental: CADx Without Predicted Probability
Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using NBI, with CADx-displayed NICE classification predictions but without any predicted probability information.
Device: CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display
CADx-assisted optical diagnosis (NBI; predicted probability not displayed). Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) with CADx-displayed NICE classification predictions for each polyp. In this arm, the CADx output is displayed without any predicted probability information.
Experimental: CADx With PPredicted Probability
Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using NBI, with CADx-displayed NICE classification predictions and accompanying predicted probability information.
Device: CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display
CADx-assisted optical diagnosis (NBI; predicted probability displayed). Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) with CADx-displayed NICE classification predictions for each polyp. In this arm, the CADx output is displayed with accompanying predicted probability information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pass rate for the "resect and discard" strategy
Time Frame: 14 days
Proportion of endoscopists who achieve ≥90% accuracy in correctly predicting the patient's recommended surveillance colonoscopy interval according to the 2020 U.S. Multi-Society Task Force (USMSTF) consensus recommendations.
14 days
Pass rate for the "diagnose and leave" strategy
Time Frame: 14 days
Proportion of endoscopists who achieve a negative predictive value (NPV) ≥90% for neoplastic lesions among rectosigmoid polyps, when predictions are made with high diagnostic confidence
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pass rate for the ESGE 2020-based "resect and discard" strategy
Time Frame: 14 days
The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the ESGE 2020 guideline.
14 days
Pass rate for the APWG 2022-based "resect and discard" strategy
Time Frame: 14 days
The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the APWG 2022 consensus.
14 days
Pass rate for the China 2023-based "resect and discard" strategy
Time Frame: 14 days
The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the Chinese 2023 consensus.
14 days
SODA-1 achievement rate
Time Frame: 14 days
The proportion of endoscopists who, when reporting high diagnostic confidence, meet the SODA-1 performance thresholds for diagnosing neoplastic pathology in diminutive rectosigmoid polyps, as assessed by sensitivity of at least 90% and specificity of at least 80%, with histopathology as the reference standard.
14 days
SODA-2 achievement rate
Time Frame: 14 days
The proportion of endoscopists who, when reporting high diagnostic confidence, meet the SODA-2 performance thresholds for diagnosing neoplastic pathology in diminutive colorectal polyps, as assessed by sensitivity of at least 80% and specificity of at least 80%, with histopathology as the reference standard.
14 days
Proportion of high-confidence optical diagnoses
Time Frame: 14 days
For each endoscopist, the percentage of polyp assessments that are labeled as high diagnostic confidence among all polyp assessments performed.
14 days
Accuracy of high-confidence optical diagnosis (neoplastic vs non-neoplastic)
Time Frame: 14 days
For each endoscopist, the percentage of correct classifications (neoplastic vs non-neoplastic) among assessments labeled as high diagnostic confidence, using histopathology as the reference standard.
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 (Actual)

January 3, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • KY2024-080-A-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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