Actively Recruiting
Comparison Between Artificial Intelligence Assisted Capsule Endoscopy and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Led by Fondazione Poliambulanza Istituto Ospedaliero · Updated on 2025-08-08
180
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of artificial intelligence (AI) to assist with Video Capsule Endoscopy (VCE) in detecting small bowel inflammation typical of Crohn's Disease (CD) in patients with suspected CD and inconclusive ileocolonoscopy results. The study aims to compare AI-assisted VCE using the SmartScan system with standard reading methods to see if AI can reduce reading time while maintaining the diagnostic accuracy and yield of traditional readings. This multicenter prospective trial focuses on identifying small bowel erosions and ulcers associated with CD.
CONDITIONS
Brief Title
Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Clinical suspicion of Crohn's Disease with or without obstructive symptoms
- Negative or aspecific inflammatory findings on ileocolonoscopy
- Signed informed consent form
You will not qualify if you...
- Known diagnosis of Crohn's Disease
- Active diverticular disease, colorectal cancer, ulcerative colitis, infectious colitis, or microscopic colitis diagnosed by endoscopy
- Positive stool tests for pathogenic bacteria, parasites, or infections within 6 months before VCE
- Known intestinal obstruction or unconfirmed small bowel patency
- Use of NSAIDs within 4 weeks before ileocolonoscopy and VCE
- Known gastrointestinal motility disorder or delayed gastric emptying
- Swallowing disorders
- Allergy or intolerance to study medications or devices
- Endoscopic placement of the capsule
- Any condition preventing study adherence
- Pregnancy
- Participation in another clinical trial involving experimental drugs or devices
- Concomitant life-threatening condition
- Chronic kidney disease with eGFR <30 mL/min/1.73 m2
- Inability to sign informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedural monitoring
Participants undergo small bowel Video Capsule Endoscopy (VCE) using a capsule system equipped with a Deep Neural Network based system called SmartScan, which automatically selects suspected lesions to create a short video of selected images.
1 visit for capsule ingestion and monitoring, plus follow-up if capsule retention is suspected
Duration - Up to 12 months
Participants are monitored through routine clinical practice visits to check for capsule retention, adverse events, and to collect clinical and laboratory data.
Follow-up visits at 6 and 12 months
Trial Site Locations
Total: 1 location
1
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Actively Recruiting
Research Team
S
Stefania Piccirelli, MD
C
Clarissa Ferrari, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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