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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT01740349
First received: November 28, 2012
Last updated: July 10, 2013
Last verified: November 2012
  Purpose

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.

Condition
Pediatrics, Colon Capsule Endoscopy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS

Resource links provided by NLM:


Further study details as provided by Azienda Policlinico Umberto I:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy in pediatric Ulcerative Colitis.


Secondary Outcome Measures:
  • To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age. [ Time Frame: Day 3 (after colonoscopy and CCE-2) ] [ Designated as safety issue: Yes ]
    Number, type and severity of adverse events with both PCCE and standard colonoscopy


Enrollment: 30
Study Start Date: August 2012
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
30 children with UC
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure. This prospective pilot study will evaluate the performance of PCCE in visualizing the colon of children with UC. All subjects to be enrolled will be appropriate candidates for standard colonoscopy based on their clinical indication.

Each subject will undergo PCCE. PCCE results will be compared with that of a colonoscopy procedure.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740349

Locations
Italy
Sapienza - University of Rome
Rome, Italy, 00161
Sponsors and Collaborators
Azienda Policlinico Umberto I
  More Information

No publications provided by Azienda Policlinico Umberto I

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giovanni Di Nardo, EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01740349     History of Changes
Other Study ID Numbers: PCCE-2 GIVEN
Study First Received: November 28, 2012
Last Updated: July 10, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on July 22, 2014