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RECRUITING
NCT07387185

AI System for Detection and Characterization of Chronic Enteropathies

Sponsor: Istituti Clinici Scientifici Maugeri SpA

View on ClinicalTrials.gov

Summary

Coeliac disease (CD) is an immune-mediated enteropathy leading to small intestinal mucosal atrophy. Diagnosis relies on serology and duodenal biopsies, but it can be complicated by patchy lesions and differential diagnosis with Non-Celiac Enteropathies (NCEs). This multicenter observational study aims to develop and validate an Artificial Intelligence (AI) system to detect and characterize small bowel mucosal atrophy and other pathological findings using endoscopic imaging. The study involves a retrospective phase for training the AI model and a prospective phase to validate its diagnostic accuracy compared to standard human assessment.

Official title: Development and Validation of an Artificial Intelligence System for Detection and Characterization of Small Bowel Mucosal Atrophy in Celiac Disease and Non-Celiac Enteropathies: A Multicenter Observational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

380

Start Date

2025-02-20

Completion Date

2028-03-01

Last Updated

2026-02-04

Healthy Volunteers

No

Locations (1)

ICS Maugeri IRCCS

Pavia, PV, Italy