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 study identifier
observational
380
1 country
1
Study Start
February 20, 2025
Actual (reported)Primary Completion
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 20, 2025
Actual (reported)January 28, 2026
Actual (reported)February 4, 2026
Actual (reported)March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Diagnostic Performance of the AI System
Evaluation of Accuracy, Sensitivity, and Specificity of the AI system in detecting intestinal mucosal atrophy and other major pathological findings compared to the gold standard (histology/expert consensus).
Through study completion (36 months)
Comparison of Diagnostic Performance (No AI-assistance vs AI-assisted)
Through study completion (36 months)
Inter-observer Agreement
Through study completion (36 months)
Adult patients (\>=18 years) with suspected or confirmed Celiac Disease or Non-Celiac Enteropathies undergoing small bowel endoscopy.
Adult patients (\>=18 years) undergoing small bowel endoscopy who do not have enteropathy or other small bowel pathological lesions (negative controls).
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.
Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy) for suspected or known celiac disease, non-celiac enteropathies or other small bowel conditions
ICS Maugeri IRCCS
Pavia, PV, 27100, Italy
First Submitted
January 28, 2026
First Posted
February 4, 2026
Study Start
February 20, 2025
Actual (reported)Primary Completion
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
Contact the study team to confirm eligibility.
Study Completion
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 4, 2026
Record last verified: 2026-01
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