Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Di… (NCT07111715) | Clinical Trial Compass
RecruitingNot Applicable
Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Italy180 participantsStarted 2025-07-21
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic yield (DY)
Timeframe: through study completion, an average of 1 year