Status:
COMPLETED
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
Lead Sponsor:
Azienda Policlinico Umberto I
Conditions:
Pediatric
Colon Capsule Endoscopy
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02199626
Start Date
September 1 2013
End Date
July 1 2014
Last Update
July 24 2014
Active Locations (1)
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1
Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome
Rome, Rome, Italy, 00161