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Clinical Trial Summary

Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.


Clinical Trial Description

Objectives Main objective To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k>0,6 Secondary objectives To compare the sensitivity and specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01820182
Study type Interventional
Source Hôpital Edouard Herriot
Contact
Status Completed
Phase N/A
Start date January 2011
Completion date June 2012

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