Sapienza - University of Rome
Rome, Italy, 00161
NCT Number: NCT01740349
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.
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Notify Me6 year–18 year
All sexes
Observational
Rome, Italy, 00161
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
ELIGIBILITY Ages Eligible for Study: 6-18 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Inclusion criteria
Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:
The presence of any of the following will exclude a subject from study enrollment:
Time frame: Day 3 (after colonoscopy and CCE-2)
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)
Number, type and severity of adverse events with both PCCE and standard colonoscopy
Azienda Policlinico Umberto I
Other
EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS
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