Actively Recruiting
Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
Led by Hospital Clinic of Barcelona · Updated on 2024-06-17
147
Participants Needed
16
Research Sites
83 weeks
Total Duration
On this page
Sponsors
H
Hospital Clinic of Barcelona
Lead Sponsor
S
Spanish Society of Digestive Endoscopy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.
You will not qualify if you...
- Known small bowel strictures detected by computed tomography (CT) or magnetic resonance imaging (MRI).
- History of esophagogastric and small bowel surgery (excluding ileocecal resection).
- Clinical contraindication for small bowel capsule endoscopy.
- Hospitalized patients.
- Presence of pacemaker or Implantable Cardioverter Defibrillator (ICD).
- Scheduled for MRI within 15 days after capsule endoscopy ingestion.
- Pregnant or actively breastfeeding patients.
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Hospital General Universitario Dr Balmis
Alicante, Spain
Not Yet Recruiting
2
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
3
Hospital del Mar
Barcelona, Spain
Not Yet Recruiting
4
Institut de Recerca Sant Pau (IR-Sant Pau)
Barcelona, Spain
Not Yet Recruiting
5
Hospital Universitario de Galdakao
Bilbao, Spain
Not Yet Recruiting
6
Hospital General Universitario Virgen la Arrixaca
El Palmar, Spain
Not Yet Recruiting
7
Hospital General Universitario de Elche
Elche, Spain
Not Yet Recruiting
8
Hospital Clínico San Carlos
Madrid, Spain
Not Yet Recruiting
9
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Not Yet Recruiting
10
Hospital General Universitario Morales Meseguer
Murcia, Spain
Not Yet Recruiting
11
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Not Yet Recruiting
12
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Not Yet Recruiting
13
Hospital Universitario Virgen Macarena
Seville, Spain
Not Yet Recruiting
14
Hospital de Terrassa
Terrassa, Spain
Not Yet Recruiting
15
Hospital General Universitario de Valencia
Valencia, Spain
Not Yet Recruiting
16
Hospital Universitario i Politècnic La Fé
Valencia, Spain
Not Yet Recruiting
Research Team
B
Begoña González Suárez, PhD
CONTACT
M
Miguel Urpí Ferreruela, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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