Evaluation Of The Pillcam™ Colon Capsule Endoscopy (Pcce-2) In Pediatric Ulcerative Colitis

Study Overview
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Brief Summary
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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 To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.

Official Title
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EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS

Conditions
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Pediatrics, Colon Capsule Endoscopy

Participation Criteria
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Eligibility Criteria
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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: diagnosis of UC made at least 3 months before the enrolment; subject was referred for standard colonoscopy and endoscopic follow-up in Ulcerative colitis signed informed consent. Exclusion criteria The presence of any of the following will exclude a subject from study enrollment: Subject has dysphagia Subject has renal insufficiency Subject is known or suspected structuring CD. Subject has a cardiac pacemaker or other implanted electro medical devices. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 30 children with UC<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 3 (after colonoscopy and CCE-2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 3 (after colonoscopy and CCE-2) |