Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
NAVIPILL
Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology
1 other identifier
interventional
147
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 27, 2024
CompletedFirst Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 17, 2024
May 1, 2024
1 year
May 30, 2024
June 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concordance correlation coefficient in small bowel exploration (per-patient analysis)
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.
From the start of recording up to 12 hours afterward
Secondary Outcomes (4)
Correlation coefficient in lesion detection (per-lesion analysis)
From the start of recording up to 12 hours afterward
Reading time in minutes
From the start of recording up to 12 hours afterward
Transit times in minutes
From the start of recording up to 12 hours afterward
Adverse events related to Navicam and/or Pillcam SB3
From the start of recording up to 24 hours afterward
Study Arms (2)
Navicam endoscopic capsule
EXPERIMENTALNavicam endoscopic capsule device for the study of small bowel pathology.
Pillcam endoscopic capsule
ACTIVE COMPARATORPillcam SB3 endoscopic capsule device for the study of small bowel pathology.
Interventions
Exploration of the small bowel by Navicam SB endoscopic capsule.
Exploration of the small bowel by Pillcam SB3 endoscopic capsule.
Eligibility Criteria
You may qualify if:
- Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Hospital General Universitario Dr Balmis
Alicante, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital del Mar
Barcelona, Spain
Institut de Recerca Sant Pau (IR-Sant Pau)
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 Clínico San Carlos
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital de Terrassa
Terrassa, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario i Politècnic La Fé
Valencia, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Begoña González Suárez, PhD
Hospital Clinic of Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 17, 2024
Study Start
May 27, 2024
Primary Completion
June 1, 2025
Study Completion
December 31, 2025
Last Updated
June 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share