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

NCT07389759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2026-07-07

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Polyps

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-03
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07389759 on ClinicalTrials.gov