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

Pediatric Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199626
• Other study ID #: CCE-2 in pediatric CD
• 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

• Colon Capsule Endoscopy
• Crohn Disease
• Pediatric

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