Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
- Conditions
- Small Intestine Disease
- Interventions
- Device: Navicam SB capsuleDevice: Pillcam SB3
- Registration Number
- NCT06462352
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief 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.
- Detailed Description
This is a prospective, multicenter, randomized, observational study involving multiple hospitals across Spain. At each site, patients will ingest both the Pillcam SB3 and Navicam capsules in a randomized order. Reading times, transit times, and diagnostic yield will be compared between the two devices. A central reading committee of experienced gastroenterologists will conduct blinded evaluations of both explorations using predefined criteria.
The primary endpoint is the diagnostic concordance between Navicam's AI-driven ProScan™ system and the conventional reading of Pillcam SB3, measured by Cohen's kappa index.
The secondary endpoints include to assess the correlation in lesion detection, video download times, gastric and small bowel transit times, total reading times, and adverse events.
The sample size is 147 patients, accounting for an expected 10% dropout rate, based on previous studies showing a diagnostic concordance kappa index of 0.6.
This study aims to establish that the AI-based Navicam capsule is at least as effective as the conventional Pillcam SB3 in diagnosing small bowel lesions, with potentially reduced reading times, thus enhancing clinical efficiency in small bowel diagnostics.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 147
- Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Navicam endoscopic capsule Navicam SB capsule Navicam endoscopic capsule device for the study of small bowel pathology. Pillcam endoscopic capsule Pillcam SB3 Pillcam SB3 endoscopic capsule device for the study of small bowel pathology.
- Primary Outcome Measures
Name Time Method Concordance correlation coefficient in small bowel exploration (per-patient analysis) From the start of recording up to 12 hours afterward To assess the concordance (k agreement) between Navicam (with ProscanTM AI-system) and Pillcam endoscopic capsule device in detecting patients with at least one significant small bowel lesion.
- Secondary Outcome Measures
Name Time Method Reading time in minutes From the start of recording up to 12 hours afterward To compare reading times of the small bowel between Navicam (Proscan) and Pillcam SB3.
Transit times in minutes From the start of recording up to 12 hours afterward To compare gastric, small bowel, and colonic transit times between Navicam and Pillcam SB3.
Correlation coefficient in lesion detection (per-lesion analysis) From the start of recording up to 12 hours afterward To assess the correlation between Navicam (AI-tool Proscan) and Pillcam in detecting small bowel lesions.
Adverse events related to Navicam and/or Pillcam SB3 From the start of recording up to 24 hours afterward Describe any adverse events during small bowel exploration.
Trial Locations
- Locations (16)
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Institut de Recerca Sant Pau (IR-Sant Pau)
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital General Universitario Dr Balmis
🇪🇸Alicante, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario de Galdakao
🇪🇸Bilbao, Spain
Hospital General Universitario Virgen la Arrixaca
🇪🇸El Palmar, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
Hospital Universitario Son Espases
🇪🇸Palma De Mallorca, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital de Terrassa
🇪🇸Terrassa, Spain
Hospital Universitario i Politècnic La Fé
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain