NCT07389759

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 363 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Colorectal Polyps

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-03
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2026-02-05
• Last updated: 2026-04-15

Locations

1 site across 1 country: China