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NCT Number: NCT07387185

AI System for Detection and Characterization of Chronic Enteropathies

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Non-celiac Enteropathies Nutritional and Metabolic Diseases Small Bowel Mucosal Atrophy or Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ICS Maugeri IRCCS

Pavia, PV, 27100, Italy

Location status: Recruiting

Location contact

Federico Biagi, MD

CONTACT

[email protected]

0382592695 ext. +39

Federico Biagi, MD

PRINCIPAL_INVESTIGATOR

About this study

The study is a multicenter observational non-profit study with a total expected duration of 36 months. It aims to address the challenges in diagnosing CD and NCEs, specifically the subjective nature of endoscopic evaluation and inter-observer variability.

The study proceeds in two phases:

  • Model Development (Retrospective): Training of Deep Learning algorithms on anonymized endoscopic images/videos to identify mucosal atrophy and other lesions (e.g., angiodysplasia, ulcers, polyps).
  • Validation (Prospective): Enrolling patients undergoing small bowel endoscopy to validate the AI system's performance.

The system aims to provide analysis to assist endoscopists, reducing missed lesions and improving diagnostic accuracy.

Validation of the AI system will be performed offline on recorded anonymized endoscopy videos collected prospectively during the validation phase.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to provide informed consent.

Treatment and study plan

Primary outcomes

  1. Diagnostic Performance of the AI System

    Time frame: Through study completion (36 months)

    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).

Secondary outcomes

  1. Comparison of Diagnostic Performance (No AI-assistance vs AI-assisted)

    Time frame: Through study completion (36 months)

    Comparison of accuracy, sensitivity, and specificity of gastroenterologists performing assessment with and without the assistance of the AI system.

  2. Inter-observer Agreement

    Time frame: Through study completion (36 months)

    Measurement of agreement between the AI system and expert gastroenterologists in evaluating the extent of mucosal atrophy.

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Biagi, MD

CONTACT

[email protected]

0382592695 ext. +39

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza
  • ASST Cremona, Cremona
  • ASST Lecco, Lecco
  • Academic Unit of Gastroenterology, Sheffield Teaching Hospitals, Sheffield, UK
  • Asst Degli Spedali Civili Di Brescia
  • Azienda Ospedale Università Padova, Padova
  • Azienda Socio-Sanitaria Territoriale (ASST) di Pavia
  • Azienda Unità Sanitaria Locale della Romagna
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policinico, Milano
  • Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
  • Fondazione Poliambulanza Istituto Ospedaliero, Brescia
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • IRCCS Policlinico San Donato, Milano
  • Valduce Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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