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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01740349

Enrollment

Registered

2012-12-04

Start date

2012-08-31

Completion date

2013-02-28

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatrics, Colon Capsule Endoscopy

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.	Day 3 (after colonoscopy and CCE-2)	Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy in pediatric Ulcerative Colitis.

Secondary

Measure	Time frame	Description
To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.	Day 3 (after colonoscopy and CCE-2)	Number, type and severity of adverse events with both PCCE and standard colonoscopy

Countries

Italy

Outcome results