NCT07125300

A Study Comparing Standard and AI-Assisted Colonoscopies for Detecting and Characterizing Colorectal Lesions in Adults Aged 50-74 Undergoing Cancer Screening

Efficacy of an Artificial Intelligence System for Lesion Detection and Characterization (CADe and CADx) During Colorectal Cancer Screening Colonoscopies: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Javier Santos Fernández · Academic / Other
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to determine whether using artificial intelligence (AI) can improve the detection and characterization of abnormal growths (polyps) during colonoscopy in adults aged 50 to 74 years who are undergoing colorectal cancer screening after a positive stool test. The main questions it aims to answer are: * Does AI assistance increase the detection of adenomas or advanced colorectal neoplasia? * Does AI provide more accurate optical diagnosis of polyps compared to standard assessment by endoscopists? Researchers will compare colonoscopies performed with AI assistance (using the CAD EYE™ system) to standard colonoscopies without AI to see if AI improves detection rates or diagnostic accuracy. Participants will: * Undergo a screening colonoscopy after a positive fecal immunochemical test (FIT) * Be randomly assigned to either an AI-assisted or standard colonoscopy group * Have any detected polyps removed and analyzed * Receive either AI-based or physician-based optical diagnosis of polyps during the procedure This study helps evaluate whether AI can make colonoscopies more effective and reduce unnecessary polyp removals.

Conditions

• Colorectal Neoplasms
• Colorectal Cancer
• Adenoma Colon Polyp

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Artificial Intelligence-Assisted Colonoscopy	The intervention involves the use of an artificial intelligence tool during screening colonoscopy. This system includes two integrated functions: * CADe (Computer-Aided Detection): Highlights suspected lesions in real time on the endoscopic video to assist in identifying polyps. * CADx (Computer-Aided Diagnosis): Provides real-time optical histology predictions to help distinguish between hyperplastic and adenomatous polyps. The AI system operates autonomously during the procedure and displays visual cues on the monitor to support the endoscopist in detecting and characterizing colorectal lesions.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: Spain