The purpose of this study is to compare the clinical findings involving the small bowel obtained with the Capso Vision Video Capsule Device to those results obtained with the PillCam SB2.
This is a prospective, randomized, comparative multi-center site study. The study will be conducted at 5 to 10 clinical sites. Up to 120 subjects will be enrolled in the study in order to obtain complete endoscopic results involving at least 98 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
121
Capsule Endoscopy system
Capsule endoscopy
Shabana F. Pasha, MD
Scottsdale, Arizona, United States
Gastro Health
Miami, Florida, United States
University of Massachusetts, Worcester
Worcester, Massachusetts, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Normal vs Abnormal, Overall Impression
The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.
Time frame: Study Completion
Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2
Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.
Time frame: Study Completion
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.
Time frame: Study Completion
Preference Between CapsoCam SV-1 and PillCam SB2
Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects
Time frame: Study Completion
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Ziad Younes, MD
Germantown, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Pacific Gastroenterology Associates GI Research Institute
Vancouver, British Columbia, Canada