Artificial-intelligence versus standard review to detect Crohn's disease on video capsule endoscopy
Comparison Between Artificial Intelligence Assisted Capsule Endoscopy and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
This trial will test whether AI-assisted video capsule endoscopy can find small-bowel Crohn's disease and shorten reading time in adults with suspected Crohn's after a non-diagnostic ileocolonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione Poliambulanza Istituto Ospedaliero Academic / other |
| Locations | 1 site (Brescia) |
| Trial ID | NCT07111715 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 with clinical suspicion of Crohn's disease and a negative or inconclusive ileocolonoscopy who can safely swallow the capsule and have confirmed small-bowel patency are ideal candidates.
Not a fit: Patients with an existing Crohn's diagnosis, known intestinal obstruction or unconfirmed patency, recent positive stool infections, inability to swallow the capsule, or contraindications to the procedure are unlikely to benefit.
Why it matters
Potential benefit: If successful, AI-assisted VCE could speed up image review and increase detection of small-bowel inflammatory lesions, enabling faster diagnosis and management for patients with suspected Crohn's disease.
How similar studies have performed: Multiple retrospective and single-center studies have shown AI can reduce VCE reading time and improve lesion detection, but this is one of the first prospective multicenter real-life evaluations of the OMOM SmartScan system.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brescia
- Fondazione Poliambulanza Istituto Ospedaliero — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.