AI System for Detection and Characterization of Chronic Enteropathies

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: Small Bowel Mucosal Atrophy or Lesions; Celiac Disease; Non-celiac Enteropathies

Study type: Observational

Funder types: Other

Identifiers

NCT07387185

CTSPV36-24

Details and patient eligibility

About

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.

Full description

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:

1. 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).
2. 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

380 participants in 3 patient groups

Enteropathy Cohort (CD/NCE)

Description:

Adult patients (\>=18 years) with suspected or confirmed Celiac Disease or Non-Celiac Enteropathies undergoing small bowel endoscopy.

Control Cohort

Description:

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

Description:

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.