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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione Poliambulanza Istituto Ospedaliero
RECRUITING
Brescia
Contact Information
Primary
Stefania Piccirelli, MD
stefania.piccirelli@poliambulanza.it
0039 0303518364
Backup
Clarissa Ferrari, PhD
clarissa.ferrari@poliambulanza.it
0039 0303518610
Time Frame
Start Date: 2025-07-21
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 180
Treatments
Suspected Crohn's Disease
Eligible patients for the study are those with clinical symptoms and laboratory results suggestive of CD who have previously undergone an ileocolonoscopy which excluded other organic pathology and/or resulted inconclusive for CD (aspecific terminal ileitis).
Sponsors
Leads: Fondazione Poliambulanza Istituto Ospedaliero

This content was sourced from clinicaltrials.gov