RecruitingNCT07387185

AI System for Detection and Characterization of Chronic Enteropathies

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


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

380 participants

Start Date

Feb 20, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria1

  • Inability to provide informed consent.

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Locations(1)

ICS Maugeri IRCCS

Pavia, PV, Italy

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NCT07387185


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