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

NCT06462352 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2024-06-17

No results posted yet for this study

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.

Conditions

  • Small Intestine Disease

Interventions

DEVICE

Navicam SB capsule

Exploration of the small bowel by Navicam SB endoscopic capsule.

DEVICE

Pillcam SB3

Exploration of the small bowel by Pillcam SB3 endoscopic capsule.

Sponsors & Collaborators

  • Spanish Society of Digestive Endoscopy

    collaborator OTHER

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Begoña González Suárez, PhD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2025-06-01
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06462352 on ClinicalTrials.gov