At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Confirmed Crohn's disease with recent mucosal disease (within 2 years) based on radiologic, endoscopic, or histologic evidence OR active disease based on clinical judgment
- ✓Willing and able to comply with study schedule and procedures
- ✕Indeterminate colitis, ulcerative colitis, or antibiotic-associated colitis
- ✕Stool positive for ova, parasites, or Clostridium difficile toxins within 3 months prior to enrollment
- ✕Other known infectious cause of abdominal symptoms
- ✕Clinical evidence of renal disease in past 6 months, defined as eGFR outside normal reference range
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Prospective, Study Comparing PillCam® Crohn's Capsule Endoscopy (CE) to Ileocolonoscopy (IC) Plus MRE for Detection of Active Crohn's Disease (CD) in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease
In Brief
A clinical study evaluating Capsule Endoscopy for Crohn Disease. Completed, enrolled 187 participants across 26 sites in 3 countries.
Detailed Summary
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline. Patient satisfaction questionnaire will be completed at baseline.
Study Details
Timeline
Interventions
At baseline subject will under the PillCam Crohn's Capsule Procedure