Clinical trial NCT06462352: Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
Official title: Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Intestine Disease
Keywords: capsule endoscopy
artificial intelligence
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Spanish Society of Digestive Endoscopy
First posted: 2024-06-17
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Concordance correlation coefficient in small bowel exploration (per-patient analysis)
timeFrame: From the start of recording up to 12 hours afterward
Secondary outcomes:
measure: Correlation coefficient in lesion detection (per-lesion analysis)
timeFrame: From the start of recording up to 12 hours afterward
measure: Reading time in minutes
timeFrame: From the start of recording up to 12 hours afterward
measure: Transit times in minutes
timeFrame: From the start of recording up to 12 hours afterward
measure: Adverse events related to Navicam and/or Pillcam SB3
timeFrame: From the start of recording up to 24 hours afterward
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario Dr Balmis
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Institut de Recerca Sant Pau (IR-Sant Pau)
city: Bilbao
country: Spain
facility: Hospital Universitario de Galdakao
city: El Palmar
country: Spain
facility: Hospital General Universitario Virgen la Arrixaca
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Terrassa
country: Spain
facility: Hospital de Terrassa
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario i Politècnic La Fé
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Begoña González Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
References: