Crohn'sRecruiting
Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY
Observational · No treatment assigned · 1 site · Fondazione Poliambulanza Istituto Ospedaliero
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Age >= 18 and <= 75 years
- Clinical suspicion of Crohn's Disease (CD) with/without occlusive symptoms
- Ileocolonoscopy: negative examination, aspecific inflammatory findings
Plus 1 more requirement(s). There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 180 participants are expected to take part.
- Start date: 2025-07-21.
- Main results expected around 2027-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Diagnostic yield (DY) (through study completion, an average of 1 year)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | Fondazione Poliambulanza Istituto Ospedaliero |
| Enrollment | 180 (estimated) |
| Start date | 2025-07-21 |
| Primary completion (est.) | 2027-12-31 |
| First posted | 2025-08-08 |
| Last updated | 2026-09-02 |
| Official title | Comparison Between Artificial Intelligence Assisted Capsule Endoscopy and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY |
| ClinicalTrials.gov ID | NCT07111715 |
Interventions
- Small bowel Video Capsule Endoscopy (VCE) using an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC), (Device)
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.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * Known diagnosis of CD * Endoscopic diagnosis of active diverticular disease, colorectal cancer, ulcerative colitis, or infectious colitis, microscopic colitis * Positive stool tests for pathogenic bacteria, Yersinia enterocolitica, parasites, C. difficile infection, fecal antigen for Giardia lamblia within 6 months before VCE * Known intestinal obstruction or unconfirmed small bowel patency * Any use of NSAIDs in the 4 weeks before ileocolonoscopy and before VCE * Known gastrointestinal motility disorder * Known or suspected delayed gastric emptying * Swallowing disorders * Allergy or other contraindications or intolerance to the medications/devices used in the study * Endoscopic placement of the capsule * Any condition that prevents adherence to the study * Pregnancy * Participation in another clinical trial involving experimental drugs or devices * Concomitant life-threatening condition * Chronic kidney disease (eGFR<30mL/min/1.73 m2) * Inability to sign the informed consent
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Poliambulanza Istituto Ospedaliero | Brescia, Brescia | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.