Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology

Small Intestine Disease Clinical Trial

— NAVIPILL  

Official title:

Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06462352
• Other study ID #: NAVIPILL
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Hospital Clinic of Barcelona
• Contact: Begoña González Suárez, PhD
• Phone: +34661334362
• Email: bgonzals[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 147
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Diseases
• Small Intestine Disease

Intervention

Device:
• Navicam SB capsule
Exploration of the small bowel by Navicam SB endoscopic capsule.
• Pillcam SB3
Exploration of the small bowel by Pillcam SB3 endoscopic capsule.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Dr Balmis	Alicante
Spain	Hospital Clínic de Barcelona	Barcelona
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	Sevilla
Spain	Hospital de Terrassa	Terrassa
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitario i Politècnic La Fé	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Spanish Society of Digestive Endoscopy

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation coefficient in lesion detection (per-lesion analysis)	To assess the correlation between Navicam (AI-tool Proscan) and Pillcam in detecting small bowel lesions.	From the start of recording up to 12 hours afterward
Secondary	Reading time in minutes	To compare reading times of the small bowel between Navicam (Proscan) and Pillcam SB3.	From the start of recording up to 12 hours afterward
Secondary	Transit times in minutes	To compare gastric, small bowel, and colonic transit times between Navicam and Pillcam SB3.	From the start of recording up to 12 hours afterward
Secondary	Adverse events related to Navicam and/or Pillcam SB3	Describe any adverse events during small bowel exploration.	From the start of recording up to 24 hours afterward