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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.

Locations
Other Locations
Spain
Hospital General Universitario Dr Balmis
NOT_YET_RECRUITING
Alicante
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Institut de Recerca Sant Pau (IR-Sant Pau)
NOT_YET_RECRUITING
Barcelona
Hospital Universitario de Galdakao
NOT_YET_RECRUITING
Bilbao
Hospital General Universitario Virgen la Arrixaca
NOT_YET_RECRUITING
El Palmar
Hospital General Universitario de Elche
NOT_YET_RECRUITING
Elche
Hospital Clínico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital General Universitario Morales Meseguer
NOT_YET_RECRUITING
Murcia
Hospital Universitario Son Espases
NOT_YET_RECRUITING
Palma De Mallorca
Hospital Universitario Nuestra Señora de Candelaria
NOT_YET_RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Hospital de Terrassa
NOT_YET_RECRUITING
Terrassa
Hospital General Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitario i Politècnic La Fé
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
Begoña González Suárez, PhD
bgonzals@clinic.cat
+34661334362
Backup
Miguel Urpí Ferreruela, MD
murpi@clinic.cat
Time Frame
Start Date: 2024-05-27
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 147
Treatments
Experimental: Navicam endoscopic capsule
Navicam endoscopic capsule device for the study of small bowel pathology.
Active_comparator: Pillcam endoscopic capsule
Pillcam SB3 endoscopic capsule device for the study of small bowel pathology.
Related Therapeutic Areas
Sponsors
Leads: Hospital Clinic of Barcelona
Collaborators: Spanish Society of Digestive Endoscopy

This content was sourced from clinicaltrials.gov