AI System for Detection and Characterization of Chronic Enteropathies

Sponsor
Istituti Clinici Scientifici Maugeri SpA
Study ID
NCT07387185
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Feb 4, 2026
Start date
Feb 20, 2025
Status verified
Jan 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
380 participants (estimated)

Arms

  • Arm: Enteropathy Cohort (CD/NCE)
    Adult patients (\>=18 years) with suspected or confirmed Celiac Disease or Non-Celiac Enteropathies undergoing small bowel endoscopy.
  • Arm: Control Cohort
    Adult patients (\>=18 years) undergoing small bowel endoscopy who do not have enteropathy or other small bowel pathological lesions (negative controls).
  • Arm: Other Small Bowel Lesion Cohort
    Adult patients (\>=18 years) undergoing small bowel endoscopy who who do not have Celiac Disease or Non-Celiac Enteropathies but have other small bowel pathological lesions.

Primary Outcome Measure

Diagnostic Performance of the AI System [ Time Frame: Through study completion (36 months) ]

Central Contacts

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