AI System for Detection and Characterization of Chronic Enteropathies

Recruiting now

Conditions studied: Celiac Disease, Small Bowel Mucosal Atrophy or Lesions, Non-celiac Enteropathies

In brief

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.

Key facts

Study ID

NCT07387185

Run by

Istituti Clinici Scientifici Maugeri SpA

People needed

380

Starts

2025-02-20

Expected to finish

2028-03-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (age ≥18 years).
• Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy)

You may not qualify if…

• Inability to provide informed consent.

Where it is running

• ICS Maugeri IRCCS — Pavia, PV, Italy (enrolling)

Full record on ClinicalTrials.gov

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