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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (age ≥18 years).

• Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy)

Locations
Other Locations
Italy
ICS Maugeri IRCCS
RECRUITING
Pavia
Contact Information
Primary
Federico Biagi, MD
federico.biagi@icsmaugeri.it
0382592695
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 380
Treatments
Enteropathy Cohort (CD/NCE)
Adult patients (\>=18 years) with suspected or confirmed Celiac Disease or Non-Celiac Enteropathies undergoing small bowel endoscopy.
Control Cohort
Adult patients (\>=18 years) undergoing small bowel endoscopy who do not have enteropathy or other small bowel pathological lesions (negative controls).
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.
Related Therapeutic Areas
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA
Collaborators: Ospedale Valduce, Como, Azienda Ospedale Università Padova, Padova, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Academic Unit of Gastroenterology, Sheffield Teaching Hospitals, Sheffield, UK, ASST Lecco, Lecco, Azienda Unità Sanitaria Locale della Romagna, Ravenna, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policinico, Milano, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS Policlinico San Donato, Milano, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, ASST Cremona, Cremona, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, ASST degli Spedali Civili di Brescia , Brescia, Azienda Socio-Sanitaria Territoriale (ASST) di Pavia

This content was sourced from clinicaltrials.gov