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

June 11, 2024 updated by: Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Alicante, Spain
        • Not yet recruiting
        • Hospital General Universitario Dr Balmis
        • Contact:
          • Luis Compañy
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Begoña González Suárez, PhD
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital del Mar
        • Contact:
          • Josep Dedeu Cuscó
      • Barcelona, Spain
        • Not yet recruiting
        • Institut de Recerca Sant Pau (IR-Sant Pau)
        • Contact:
          • Antonio Giordano, PhD
      • Bilbao, Spain
        • Not yet recruiting
        • Hospital Universitario de Galdakao
        • Contact:
          • Margarita Durán
      • El Palmar, Spain
        • Not yet recruiting
        • Hospital General Universitario Virgen la Arrixaca
        • Contact:
          • Juan Egea Valenzuela, PhD
      • Elche, Spain
        • Not yet recruiting
        • Hospital General Universitario de Elche
        • Contact:
          • Javier Sola Vera
      • Madrid, Spain
        • Not yet recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
          • Oscar Nogales Ricón
        • Contact:
          • Javier García Lledó
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Francisco Sánchez Ceballos
      • Murcia, Spain
        • Not yet recruiting
        • Hospital General Universitario Morales Meseguer
        • Contact:
          • Enrique Pérez Cuadrado, PhD
      • Palma De Mallorca, Spain
        • Not yet recruiting
        • Hospital Universitario Son Espases
        • Contact:
          • Carmen Garrido
      • Santa Cruz De Tenerife, Spain
        • Not yet recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
        • Contact:
          • Mileidis San Juan Acosta, PhD
        • Contact:
          • Pilar Borque Barrera
      • Sevilla, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Angel Caunedo
      • Terrassa, Spain
        • Not yet recruiting
        • Hospital de Terrassa
        • Contact:
          • Sara Galter
      • Valencia, Spain
        • Not yet recruiting
        • Hospital General Universitario de Valencia
        • Contact:
          • Marisol Luján Sanchis
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitario i Politècnic La Fé
        • Contact:
          • Vicente Pons Beltrán, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Navicam endoscopic capsule
Navicam endoscopic capsule device for the study of small bowel pathology.
Device: Navicam SB capsule
Exploration of the small bowel by Navicam SB endoscopic capsule.
Active Comparator: Pillcam endoscopic capsule
Pillcam SB3 endoscopic capsule device for the study of small bowel pathology.
Device: Pillcam SB3
Exploration of the small bowel by Pillcam SB3 endoscopic capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance correlation coefficient in small bowel exploration (per-patient analysis)
Time Frame: From the start of recording up to 12 hours afterward
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation coefficient in lesion detection (per-lesion analysis)
Time Frame: From the start of recording up to 12 hours afterward
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
Reading time in minutes
Time Frame: From the start of recording up to 12 hours afterward
To compare reading times of the small bowel between Navicam (Proscan) and Pillcam SB3.
From the start of recording up to 12 hours afterward
Transit times in minutes
Time Frame: From the start of recording up to 12 hours afterward
To compare gastric, small bowel, and colonic transit times between Navicam and Pillcam SB3.
From the start of recording up to 12 hours afterward
Adverse events related to Navicam and/or Pillcam SB3
Time Frame: From the start of recording up to 24 hours afterward
Describe any adverse events during small bowel exploration.
From the start of recording up to 24 hours afterward

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Spanish Society of Digestive Endoscopy

Investigators

  • Principal Investigator: Begoña González Suárez, PhD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAVIPILL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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