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Completed

NCT Number: NCT02199626

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

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.

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Key information

Conditions

Pediatric Colon Capsule Endoscopy

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome

Rome, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Second generation of colon capsule endoscopy (GIVEN IMAGING)

Device

Primary outcomes

  1. 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.

    Time frame: 3 days

    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).

Secondary outcomes

  1. To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease.

    Time frame: two days

    Number, type and severity of adverse events with second generation of Crohn's disease.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2014
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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