Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology
NCT Number: NCT06462352
Acronym: NAVIPILL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Small Intestine Disease
Interventions: DEVICE: Navicam SB capsule|DEVICE: Pillcam SB3
Sponsor: Hospital Clinic of Barcelona
Collaborators: Spanish Society of Digestive Endoscopy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 147
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-27
Completion Date: 2025-12-31
Locations: Hospital General Universitario Dr Balmis, Alicante, Spain|Hospital Clínic de Barcelona, Barcelona, 08036, 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, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: 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|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|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|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