NCT07111715Recruiting
Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Comparison Between Artificial Intelligence Assisted Capsule Endoscopy and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
The diagnosis of Crohn's Disease (CD) is based on a combination of clinical, biochemical (serological and fecal), endoscopic, radiological, and histological investigations. In the absence of obstructive symptoms or known stenosis, European guidelines recommend to investigate the small intestine using Video Capsule Endoscopy (VCE) if ileocolonoscopy is not decisive. To reduce the reading time of VCE and increase the number of identified lesions during the examination, various artificial intelligence software/tools have been developed in recent decades. This study aims to be the first prospective multicentric real-life trial to evaluate AI-assisted VCE using SmartScan in identifying typical mucosal abnormalities of the small intestine in patients with suspected CD and its ability to reduce reading time while maintaining the same diagnostic yield and diagnostic accuracy of standard reading. The objective of the study is to evaluate the role of AI-assisted VCE using the OMOM SmartScan in detecting typical small bowel inflammatory lesions (i.e. erosions and ulcers) in patients with suspected CD, and comparing AI with standard reading.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 4 Jul 2025
- Start date
- 21 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Diseases
- Crohn's disease
- NCT number
- NCT07111715
What you commit to
- Study type: Observational
- Planned participants: 180
- From 21 Jul 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive stool tests for pathogenic bacteria, Yersinia enterocolitica, parasites, C. difficile infection, fecal antigen for Giardia lamblia within 6 months before VCE
- Any use of NSAIDs in the 4 weeks before ileocolonoscopy and before VCE
- Participation in another clinical trial involving experimental drugs or devices
- Concomitant life-threatening condition
Other illness
- Endoscopic diagnosis of active diverticular disease, colorectal cancer, ulcerative colitis, or infectious colitis, microscopic colitis
- Known gastrointestinal motility disorder
- Swallowing disorders
- Allergy or other contraindications or intolerance to the medications/devices used in the study
- Any condition that prevents adherence to the study
Lab values
- Chronic kidney disease (eGFR\<30mL/min/1.73 m2)
Other
- Known diagnosis of CD
- Known intestinal obstruction or unconfirmed small bowel patency
- Known or suspected delayed gastric emptying
- Endoscopic placement of the capsule
- Pregnancy
- Inability to sign the informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Poliambulanza Istituto Ospedaliero Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.