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| Name | Class |
|---|---|
| Fondazione IRCCS Policlinico San Matteo, Pavia, Italy | UNKNOWN |
| Valduce Hospital | OTHER |
| Azienda Ospedale Università Padova, Padova | UNKNOWN |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion (36 months) |
| Inter-observer Agreement |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Biagi, MD | Contact | 0382592695 | +39 | federico.biagi@icsmaugeri.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICS Maugeri IRCCS | Recruiting | Pavia | PV | 27100 | Italy |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
| ASST Cremona, Cremona | UNKNOWN |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino | UNKNOWN |
| Fondazione Poliambulanza Istituto Ospedaliero, Brescia | UNKNOWN |
| Asst Degli Spedali Civili Di Brescia | OTHER |
| IRCCS Policlinico San Donato, Milano | UNKNOWN |
| Azienda Socio-Sanitaria Territoriale (ASST) di Pavia | UNKNOWN |
| Azienda Unità Sanitaria Locale della Romagna | OTHER |
| ASST Lecco, Lecco | OTHER |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policinico, Milano | UNKNOWN |
| Academic Unit of Gastroenterology, Sheffield Teaching Hospitals, Sheffield, UK | UNKNOWN |
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Measurement of agreement between the AI system and expert gastroenterologists in evaluating the extent of mucosal atrophy. |
| Through study completion (36 months) |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |