AI reads capsule endoscopy videos to hunt for Crohn's lesions
NCT ID NCT07111715
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This trial tests whether an AI system called SmartScan can match standard reading when reviewing capsule endoscopy videos for signs of Crohn's disease. Adults with suspected Crohn's but unclear colonoscopy results will swallow a camera capsule that records images of the small intestine. The AI selects suspicious frames to create a short video, and researchers compare its findings and reading time against the traditional full review.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Small bowel video capsule endoscopy with an AI-based SmartScan system that automatically selects suspected lesions
- What this could lead to
- If it works, AI-assisted reading could speed up Crohn's diagnosis while keeping accuracy, helping more patients get answers faster.
- What could go wrong
- This is an early, 180-person trial. The AI might miss lesions that standard reading catches, or the time savings may not hold up in real-world use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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).
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione Poliambulanza Istituto Ospedaliero
RECRUITINGBrescia, Brescia, 25124, Italy
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