At a glance
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Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
In Brief
A clinical study evaluating PillCam Colon 2 and Colonoscopy for Colorectal Lesions. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy. This study will also use to evaluate the administrative feasibility and data management of study design.
Study Details
Timeline
Interventions
Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE). Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.
The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.