Trials / Completed
CompletedNCT02199626
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Azienda Policlinico Umberto I · Academic / Other
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Second generation of colon capsule endoscopy (GIVEN IMAGING) |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2014-01-01
- Completion
- 2014-07-01
- First posted
- 2014-07-24
- Last updated
- 2014-07-24
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02199626. Inclusion in this directory is not an endorsement.