At a glance
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Evaluation of the PillCam® Platform With the PillCam Crohn's Disease Capsule in Visualization of Lesions in the Small Bowel and Colon That May Indicate Crohn's Disease
In Brief
A Phase 2 clinical trial evaluating Pillcam colon capsule and PillCam™ Prep Procedure and Ileocolonoscopy for Crohn's Disease. Completed, enrolled 75 participants across 1 site.
Detailed Summary
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
Study Details
Timeline
Interventions
PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure • Ileocolonoscopy with intubation of terminal ileum