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AI System for Detection and Characterization of Chronic Enteropathies

NCT07387185 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 380

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

  • Celiac Disease
  • Small Bowel Mucosal Atrophy or Lesions
  • Non-celiac Enteropathies

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

    collaborator UNKNOWN

  • Ospedale Valduce, Como

    collaborator UNKNOWN

  • Azienda Ospedale Università Padova, Padova

    collaborator UNKNOWN

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • ASST Cremona, Cremona

    collaborator UNKNOWN

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    collaborator UNKNOWN

  • Fondazione Poliambulanza Istituto Ospedaliero, Brescia

    collaborator UNKNOWN

  • ASST degli Spedali Civili di Brescia , Brescia

    collaborator UNKNOWN

  • IRCCS Policlinico San Donato, Milano

    collaborator UNKNOWN

  • Azienda Socio-Sanitaria Territoriale (ASST) di Pavia

    collaborator UNKNOWN

  • Azienda Unità Sanitaria Locale della Romagna, Ravenna

    collaborator UNKNOWN

  • ASST Lecco, Lecco

    collaborator UNKNOWN

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policinico, Milano

    collaborator UNKNOWN

  • Academic Unit of Gastroenterology, Sheffield Teaching Hospitals, Sheffield, UK

    collaborator UNKNOWN

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2028-03-01
Completion
2028-03-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07387185 on ClinicalTrials.gov