Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology
Hospital Clinic of Barcelona
147 participants
May 27, 2024
INTERVENTIONAL
Conditions
Summary
Since its introduction in 2001, small bowel capsule endoscopy has been pivotal in diagnosing small bowel pathology due to its minimally invasive nature and high diagnostic accuracy. However, the technology has limitations, including prolonged reading times and the need for specialized endoscopists. The Navicam endoscopic capsule, leveraging artificial intelligence (AI) with ProScan™ for automated reading, promises to address these limitations by reducing reading times and enhancing diagnostic efficiency. This study aims to assess the diagnostic concordance and to compare the efficiency of the AI-based Navicam capsule with the conventional Pillcam SB3 in the exploration of the small bowel.
Eligibility
Inclusion Criteria1
- Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.
Exclusion Criteria11
- Patients with known small bowel strictures detected by computed tomography (CT) or magnetic resonance imaging (MRI).
- Patients with a history of esophagogastric and small bowel surgery (excluding ileocecal resection).
- Patients with a clinical contraindication for small bowel capsule endoscopy.
- Hospitalized patients.
- Patients with pacemaker or Implantable Cardioverter Defibrillator (ICD).
- Patients scheduled for a MRI within 15 days after capsule endoscopy ingestion.
- Pregnant or actively breastfeeding patients.
- Patients with swallowing disorders requiring endoscopic placement of the capsule.
- Simultaneous participation in another clinical trial using any investigational drug or device.
- Concurrent life-threatening pathology or condition.
- Inability to sign the informed consent form.
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Interventions
Exploration of the small bowel by Navicam SB endoscopic capsule.
Exploration of the small bowel by Pillcam SB3 endoscopic capsule.
Locations(16)
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NCT06462352