AI System for Detection and Characterization of Chronic Enteropathies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (age ≥18 years).
Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy)
Disqualifiers
Inability to provide informed consent.
Trial population
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
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
380 Participants
are grouped into 3 trial groupsGroup A: Enteropathy Cohort (CD/NCE)
Group B: Control Cohort
Group C: Other Small Bowel Lesion Cohort
Trial outcomes
Primary outcomes
1
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).
Time frame
Through study completion (36 months)Secondary outcomes
1
Comparison of Diagnostic Performance (No AI-assistance vs AI-assisted)
Comparison of accuracy, sensitivity, and specificity of gastroenterologists performing assessment with and without the assistance of the AI system.
Time frame
Through study completion (36 months)2
Inter-observer Agreement
Measurement of agreement between the AI system and expert gastroenterologists in evaluating the extent of mucosal atrophy.
Time frame
Through study completion (36 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Collaborator
Valduce Hospital
Collaborator
Azienda Ospedale Università Padova, Padova
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
ASST Cremona, Cremona
Collaborator
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Collaborator
Fondazione Poliambulanza Istituto Ospedaliero, Brescia
Collaborator
Asst Degli Spedali Civili Di Brescia
Collaborator
IRCCS Policlinico San Donato, Milano
Collaborator
Azienda Socio-Sanitaria Territoriale (ASST) di Pavia
Collaborator
Azienda Unità Sanitaria Locale della Romagna
Collaborator
ASST Lecco, Lecco
Collaborator
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policinico, Milano
Collaborator
Academic Unit of Gastroenterology, Sheffield Teaching Hospitals, Sheffield, UK
Collaborator
Source ClinicalTrials.gov