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OpenTrials
Completed

NCT Number: NCT01740349

Evaluation Of The Pillcam™ Colon Capsule Endoscopy (Pcce-2) In Pediatric Ulcerative Colitis

This prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy.

This study aims

1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. 2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sapienza - University of Rome

Rome, Italy, 00161

Who can participate

Healthy volunteers accepted: No

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

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 UC made at least 3 months before the enrolment;
  • subject was referred for standard colonoscopy and endoscopic follow-up in Ulcerative colitis
  • 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 or suspected structuring CD.
  • Subject has a cardiac pacemaker or other implanted electro medical devices.
  • Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  • 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 clinical judgment of the investigator.

Treatment and study plan

Primary outcomes

  1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.

    Time frame: Day 3 (after colonoscopy and CCE-2)

    Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy in pediatric Ulcerative Colitis.

Secondary outcomes

  1. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.

    Time frame: Day 3 (after colonoscopy and CCE-2)

    Number, type and severity of adverse events with both PCCE and standard colonoscopy

Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Registry information

Official study title

EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Dec 4, 2012
Registry last updated
Jul 11, 2013

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.