SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).

Study Overview
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Brief Summary
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This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and the second generation of colon capsule in comparison second generation of colon capsule endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast ultrasonography (SICUS) and endoscopy (upper and lower). This study aims To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the evaluation of pediatric Crohn's disease. To evaluate the safety of CCE-2 in pediatric CD.

Official Title
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SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).

Conditions
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Pediatric, Colon Capsule Endoscopy

Intervention / Treatment
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* Device: Second generation of colon capsule endoscopy (GIVEN IMAGING)


Participation Criteria
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Eligibility Criteria
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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 Crohn's Disease made at least 3 months before the enrolment; subject was referred for endoscopic and imaging follow-up in Crohn's Disease 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 structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS). 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 magnetic resonance enterography findings and 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCE-2<br>Second generation of Colon capsule endoscopy in pediatric Crohn's disease | Device: Second generation of colon capsule endoscopy (GIVEN IMAGING)<br> <br> |

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 Second generation of Colon Capsule Endoscopy with magnetic resonance enterography, small intestine contrast ultrasonography and endoscopy in the evaluation of pediatric Crohn's disease. | Accuracy parameters (sensitivity, specificity, NPV, PPV) of second generation of colon capsule endoscopy compared to endoscopy, to magnetic resonance enterography and to small intestine contrast ultrasonography in evaluating disease activity in pediatric CD. The disease activity will be evaluated with a validated score (SES-CD) for endoscopy and imaging tool (damage-score). | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease. | Number, type and severity of adverse events with second generation of Crohn's disease. | two days |