Artificial-intelligence versus standard review to detect Crohn's disease on video capsule endoscopy

Is this trial a fit for you?

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

What this trial studies

This prospective multicenter real-life observational study compares OMOM SmartScan AI-assisted video capsule endoscopy (VCE) with standard human reading in adults with suspected Crohn's disease and negative or inconclusive ileocolonoscopy. Enrolled patients undergo VCE after confirming small-bowel patency when needed, and readers measure diagnostic yield, diagnostic accuracy, and reading time for AI-assisted versus standard reads. Patient-reported outcome measures and routine clinical, laboratory, and radiological data are collected to contextualize findings. The primary goal is to determine whether SmartScan maintains diagnostic performance while reducing the time needed to review VCE studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>= 18 and \<= 75 years
* Clinical suspicion of Crohn's Disease (CD) with/without occlusive symptoms
* Ileocolonoscopy: negative examination, aspecific inflammatory findings
* Signed informed consent form

Exclusion Criteria:

* Known diagnosis of CD
* Endoscopic diagnosis of active diverticular disease, colorectal cancer, ulcerative colitis, or infectious colitis, microscopic colitis
* Positive stool tests for pathogenic bacteria, Yersinia enterocolitica, parasites, C. difficile infection, fecal antigen for Giardia lamblia within 6 months before VCE
* Known intestinal obstruction or unconfirmed small bowel patency
* Any use of NSAIDs in the 4 weeks before ileocolonoscopy and before VCE
* Known gastrointestinal motility disorder
* Known or suspected delayed gastric emptying
* Swallowing disorders
* Allergy or other contraindications or intolerance to the medications/devices used in the study
* Endoscopic placement of the capsule
* Any condition that prevents adherence to the study
* Pregnancy
* Participation in another clinical trial involving experimental drugs or devices
* Concomitant life-threatening condition
* Chronic kidney disease (eGFR\<30mL/min/1.73 m2)
* Inability to sign the informed consent

Where it's running

• Fondazione Poliambulanza Istituto Ospedaliero
  Brescia, Brescia, Italy Recruiting

Study contacts

• Principal investigator: Stefania Piccirelli, MD — Fondazione Poliambulanza
• Study coordinator: Stefania Piccirelli, MD
• Email: stefania.piccirelli@poliambulanza.it
• Phone: 0039 0303518364

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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.