Comparing AI and traditional capsule endoscopy for small bowel diseases
Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology
This study tests whether a new AI-based capsule for looking at small bowel diseases works better than the traditional capsule by comparing how quickly and accurately both can diagnose issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 16 sites (Alicante and 15 other locations) |
| Trial ID | NCT06462352 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an AI-based capsule endoscopy system, Navicam, compared to the conventional Pillcam SB3 in diagnosing small bowel diseases. Patients will ingest both capsules in a randomized order, allowing for a direct comparison of reading times, diagnostic yield, and efficiency. A central committee of gastroenterologists will conduct blinded evaluations to assess diagnostic concordance and other key metrics. The study aims to demonstrate that the AI-driven system can enhance diagnostic efficiency while maintaining accuracy.
Who should consider this trial
Good fit: Ideal candidates are outpatients over 18 years old who require small bowel exploration via capsule endoscopy.
Not a fit: Patients with known small bowel strictures, recent surgeries, or contraindications for capsule endoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of small bowel diseases, improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results for AI applications in medical diagnostics, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital. Exclusion Criteria: * 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.
Where this trial is running
Alicante and 15 other locations
- Hospital General Universitario Dr Balmis — Alicante, Spain (Not_yet_recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital del Mar — Barcelona, Spain (Not_yet_recruiting)
- Institut de Recerca Sant Pau (IR-Sant Pau) — Barcelona, Spain (Not_yet_recruiting)
- Hospital Universitario de Galdakao — Bilbao, Spain (Not_yet_recruiting)
- Hospital General Universitario Virgen la Arrixaca — El Palmar, Spain (Not_yet_recruiting)
- Hospital General Universitario de Elche — Elche, Spain (Not_yet_recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Not_yet_recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Not_yet_recruiting)
- Hospital General Universitario Morales Meseguer — Murcia, Spain (Not_yet_recruiting)
- Hospital Universitario Son Espases — Palma de Mallorca, Spain (Not_yet_recruiting)
- Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife, Spain (Not_yet_recruiting)
- Hospital Universitario Virgen Macarena — Seville, Spain (Not_yet_recruiting)
- Hospital de Terrassa — Terrassa, Spain (Not_yet_recruiting)
- Hospital General Universitario de Valencia — Valencia, Spain (Not_yet_recruiting)
- Hospital Universitario i Politècnic La Fé — Valencia, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Begoña González Suárez, PhD — Hospital Clinic of Barcelona
- Study coordinator: Begoña González Suárez, PhD
- Email: bgonzals@clinic.cat
- Phone: +34661334362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.