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

Phase 4

Completed

• Conditions: Colon Capsule Endoscopy; Pediatric
• Interventions: Device: Second generation of colon capsule endoscopy (GIVEN IMAGING)

• Registration Number: NCT02199626
• Lead Sponsor: Azienda Policlinico Umberto I

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-01
• Status Verified: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-23
• Last Update Submitted: 2014-07-23
• Study First Posted: 2014-07-24
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCE-2	Second generation of colon capsule endoscopy (GIVEN IMAGING)	Second generation of Colon capsule endoscopy in pediatric Crohn's disease

Primary Outcome Measures

Name	Time	Method
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.	3 days	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).

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease.	two days	Number, type and severity of adverse events with second generation of Crohn's disease.

Trial Locations

Locations (1)

Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome; 🇮🇹 Rome, Italy