NCT07362524

AI-Assisted Real-Time Endoscopic Characterization of Diminutive Colorectal Polyps in Non-Academic Hospitals

Artificial Intelligence-assisted Optical Diagnosis for the Resect-and-discard Strategy in Clinical Practice in Non-academic Hospitals: a Randomized Controlled Study

• Status: Not Yet 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
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Colorectal Polyps

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-15
• Primary completion: 2026-11-15
• Completion: 2026-11-15
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

2 sites across 1 country: China