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Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY

Recruitingn/aAges 18 Years - 75 YearsAllFondazione Poliambulanza Istituto Ospedaliero
NCT07111715 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Small bowel Video Capsule Endoscopy (VCE) using an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC),
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Where

1 site
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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