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NCT07111715

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

Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2025-07-21

Completion Date

2028-12-31

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy