NCT07389759

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
363

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 29, 2026

Last Update Submit

April 12, 2026

Conditions

Colorectal Polyps

Outcome Measures

Primary Outcomes (2)

  • Pass rate for the "resect and discard" strategy

    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

    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 Outcomes (7)

  • Pass rate for the ESGE 2020-based "resect and discard" strategy

    14 days

  • Pass rate for the APWG 2022-based "resect and discard" strategy

    14 days

  • Pass rate for the China 2023-based "resect and discard" strategy

    14 days

  • SODA-1 achievement rate

    14 days

  • SODA-2 achievement rate

    14 days

  • +2 more secondary outcomes

Study Arms (3)

Standard Colonoscopy (No CADx Assistance)

NO INTERVENTION

Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) without any CADx assistance.

CADx Without Predicted Probability

EXPERIMENTAL

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 With PPredicted Probability

EXPERIMENTAL

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

Interventions

CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability DisplayDEVICE

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.

CADx Without Predicted Probability
CADx-Assisted Endoscopic Diagnosis System With Predicted Probability DisplayDEVICE

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.

CADx With PPredicted Probability

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endoscopists with NBI experience

You may not qualify if:

  • Endoscopists without colonoscopy and NBI experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

January 3, 2026

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)