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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02199626
Other study ID # CCE-2 in pediatric CD
Secondary ID
Status Completed
Phase Phase 4
First received July 2, 2014
Last updated July 23, 2014
Start date September 2013
Est. completion date July 2014

Study information

Verified date July 2014
Source Azienda Policlinico Umberto I
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Italy Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome Rome

Sponsors (1)

Lead Sponsor Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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).
3 days No
Secondary To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease. Number, type and severity of adverse events with second generation of Crohn's disease. two days Yes
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