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

Azienda Policlinico Umberto I

Status and phase

Completed

Phase 4

Conditions

Colon Capsule Endoscopy

Pediatric

Treatments

Device: Second generation of colon capsule endoscopy (GIVEN IMAGING)

Study type

Interventional

Funder types

Other

Identifiers

NCT02199626

CCE-2 in pediatric CD

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.