AI-assisted capsule endoscopy for suspected Crohn disease in the small intestine
Tests AI-assisted capsule camera reading to find small bowel lesions in suspected Crohn disease.
Plain-language title generated from the registry record
Registry title: Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Key facts
- Where
- Brescia, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07111715, who can take part
Where in Italy
- Fondazione Poliambulanza Istituto OspedalieroBrescia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Poliambulanza Istituto Ospedaliero
- Trial code
- NCT07111715
- Record updated
- 2 September 2026
- Original description
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.Read full original descriptionShow less
Comparison Between Artificial Intelligence Assisted Capsule Endoscopy and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
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.
Inclusion: 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: 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; 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; Chronic kidney disease (eGFR<30mL/min/1.73 m2); 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.