Pediatric Clinical Trial
Official title:
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are
candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System
and the second generation of colon capsule in comparison second generation of colon capsule
endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast
ultrasonography (SICUS) and endoscopy (upper and lower).
This study aims
1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the
evaluation of pediatric Crohn's disease.
2. To evaluate the safety of CCE-2 in pediatric CD.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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