RecruitingNCT07111715

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

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


Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Enrollment

180 participants

Start Date

Jul 21, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing an AI system to standard reading of capsule endoscopy (a swallowed camera pill) in people being investigated for possible Crohn's disease. The goal is to see whether AI can detect Crohn's-related changes in the small bowel more accurately or efficiently than standard methods. **You may be eligible if...** - You are between 18 and 75 years old - You are being investigated for possible Crohn's disease with or without bowel obstruction symptoms - Your colonoscopy was either normal or showed only mild non-specific inflammation - You have signed informed consent **You may NOT be eligible if...** - You have already been diagnosed with Crohn's disease - You have other bowel conditions (ulcerative colitis, colorectal cancer, active diverticular disease, microscopic colitis) - You have a known bowel obstruction or confirmed poor bowel transit - You have used NSAIDs (anti-inflammatory pain medication) in the 4 weeks before the capsule study - You are pregnant - You have a swallowing disorder or delayed stomach emptying - You have chronic kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmall 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.


Locations(1)

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy

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NCT07111715


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