Actively Recruiting
Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Led by Fondazione Poliambulanza Istituto Ospedaliero · Updated on 2025-08-08
180
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �38; 18 and �3C= 75 years
- Clinical suspicion of Crohn's Disease (CD) with or without occlusive symptoms
- Ileocolonoscopy showing negative examination or aspecific inflammatory findings
- Signed informed consent form
You will not qualify if you...
- Known diagnosis of Crohn's Disease (CD)
- Endoscopic diagnosis of active diverticular disease, colorectal cancer, ulcerative colitis, infectious colitis, or microscopic colitis
- Positive stool tests for pathogenic bacteria, Yersinia enterocolitica, parasites, C. difficile infection, or fecal antigen for Giardia lamblia within 6 months before VCE
- Known intestinal obstruction or unconfirmed small bowel patency
- 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, contraindication, or intolerance to study medications or devices
- Endoscopic placement of the capsule
- Any condition preventing adherence to the study
- Pregnancy
- Participation in another clinical trial involving experimental drugs or devices
- Concomitant life-threatening condition
- Chronic kidney disease with eGFR <30 mL/min/1.73 m2
- Inability to sign the informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Actively Recruiting
Research Team
S
Stefania Piccirelli, MD
CONTACT
C
Clarissa Ferrari, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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