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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
73
Patients inclusion following inclusion criterias Randomization of capsule ingestion order Videocapsule recording by the two capsules Reading of the two capsules films in randomized order by two different readers in each center Reviewing of discordant capsule films by an expert panel
number of discordant films between the two capsules with two different readers
Reading of the two capsules film is randomized order by two different readers in each center
Time frame: 14 days
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