Small bowel Video Capsule Endoscopy (VCE) using an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC),
Small bowel Video Capsule Endoscopy (VCE) using an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC),: Small bowel Video Capsule Endoscopy (VCE) will be performed using the an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC), which is able to automatically select suspected lesions thus creating a very short video constituted only by selected images.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Diagnostic yield (DY) — through study completion, an average of 1 year Non-inferiority of AI-assisted reading (AIR) compared to standard reading (SR) in detecting (diagnostic yield - DY) typical lesions of suspected CD (erosions and/or ulcers and/or stenosis).
Trial sites (1)
Facility
City
Region
Status
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Brescia
Recruiting
More Fondazione Poliambulanza Istituto Ospedaliero trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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