Clinical trial Recruiting at 1 site Observational Ages 18 and up

AI system to detect and describe small-bowel mucosal damage in celiac and other enteropathies

Official 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

Run by Istituti Clinici Scientifici Maugeri SpA · NCT07387185 · Data updated 2026-11-12

This project will test if an artificial intelligence system can find and describe small-bowel mucosal atrophy and other lesions in adults having small-bowel endoscopy or capsule endoscopy.

More Celiac Disease trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment380 (estimated)
SponsorIstituti Clinici Scientifici Maugeri SpA
Academic / other
Locations1 site (Pavia, PV)
StatusRecruiting
StartedFebruary 20, 2025
Main results expectedMarch 1, 2028
Study endsMarch 1, 2028
Registry record updatedFebruary 4, 2026
Trial IDNCT07387185 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 and older who are undergoing small-bowel endoscopy or capsule endoscopy for suspected celiac disease or other enteropathies and who can give informed consent are ideal candidates.

Probably not a fit

Children under 18, patients who do not undergo endoscopic imaging or cannot provide informed consent, and cases where diagnosis depends solely on non-endoscopic tests are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational project will develop a deep-learning AI using anonymized retrospective endoscopy images and videos, then prospectively validate its performance on recorded procedures. In the retrospective phase, algorithms are trained to recognize mucosal atrophy and other lesions such as angiodysplasia, ulcers, and polyps. In the prospective phase, adult patients undergoing small-bowel endoscopy or capsule endoscopy will have their recorded videos analyzed offline by the AI and compared to standard human interpretation and biopsy results where available. The aim is to reduce missed lesions and decrease inter-observer variability in endoscopic characterization.

Why it matters

Potential benefit: If successful, the AI could help endoscopists detect and characterize small-bowel lesions more reliably, reducing missed diagnoses and improving diagnostic confidence.

How similar studies have gone: AI and deep-learning tools have shown promise in detecting gastrointestinal lesions and capsule endoscopy abnormalities, but application specifically for celiac-related mucosal atrophy is relatively novel and still being validated.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • ICS Maugeri IRCCS
    Pavia, Pv, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.