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

NCT07111715 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-08-08

No results posted yet for this 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.

Conditions

  • Crohn Disease (CD)

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.

Sponsors & Collaborators

  • Fondazione Poliambulanza Istituto Ospedaliero

    lead OTHER

Principal Investigators

  • Cristiano Spada, Prof · Fondazione Poliambulanza, Policlinico A Gemelli

  • Paola Cesaro, PhD · Fondazione Poliambulanza

  • Stefania Piccirelli, MD · Fondazione Poliambulanza

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-21
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111715 on ClinicalTrials.gov