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

NCT02199626 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-07-24

No results posted yet for this study

Summary

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

1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the evaluation of pediatric Crohn's disease.
2. To evaluate the safety of CCE-2 in pediatric CD.

Conditions

  • Pediatric
  • Colon Capsule Endoscopy

Interventions

DEVICE

Second generation of colon capsule endoscopy (GIVEN IMAGING)

Sponsors & Collaborators

  • Azienda Policlinico Umberto I

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-01-31
Completion
2014-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02199626 on ClinicalTrials.gov