Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462352
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-30
Brief Title:
Multicenter Study Comparing AI-Based Navicam vs Conventional Pillcam in Small Bowel Pathology
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Multicenter Study Comparing the Artificial Intelligence-Based Navicam Endoscopic Capsule With the Conventional Pillcam Endoscopic Capsule in Small Bowel Pathology
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAVIPILL
Brief 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
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
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 Navicams AI-driven ProScan system and the conventional reading of Pillcam SB3 measured by Cohens 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 06
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
The primary endpoint is the diagnostic concordance between Navicams AI-driven ProScan system and the conventional reading of Pillcam SB3 measured by Cohens 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 06
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None