This prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims 1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. 2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.
Study Type
OBSERVATIONAL
Enrollment
30
Sapienza - University of Rome
Rome, Italy, Italy
To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy in pediatric Ulcerative Colitis.
Time frame: Day 3 (after colonoscopy and CCE-2)
To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.
Number, type and severity of adverse events with both PCCE and standard colonoscopy
Time frame: Day 3 (after colonoscopy and CCE-2)
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