AI reads capsule endoscopy videos to hunt for Crohn's lesions

NCT ID NCT07111715

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Fondazione Poliambulanza Istituto Ospedaliero

    RECRUITING

    Brescia, Brescia, 25124, Italy

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