AI-assisted capsule endoscopy for suspected Crohn disease in the small intestine

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with suspected Crohn's disease whose colon and ileum exam was negative or showed only non-specific inflammation. It tests an AI-assisted capsule camera exam of the small bowel.

Age

18 to 75 years

Sex

All sexes

Disease stage

Suspected Crohn's disease, with or without blockage symptoms. Ileocolonoscopy was negative or showed only non-specific inflammatory findings.

Earlier treatment

Must not have used NSAIDs in the 4 weeks before the ileocolonoscopy and before the capsule exam.

Biomarker or test result

Must not have positive stool tests for harmful bacteria, parasites, C. difficile or Giardia lamblia within 6 months before the capsule exam.

Main reasons for not taking part

• Known diagnosis of Crohn's disease
• Diverticular disease, colorectal cancer, ulcerative colitis, infectious or microscopic colitis
• Known bowel blockage or unconfirmed small bowel patency
• Pregnancy
• Chronic kidney disease (eGFR<30mL/min/1.73 m2)

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 75 years old?YesNo

What the trial wants to find out

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.

The group in the trial

• 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).

  Treatment: Small bowel Video Capsule Endoscopy (VCE) using an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC),