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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Azienda Policlinico Umberto I

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Azienda Policlinico Umberto I

Dates:
Date Received: November 28, 2012
Date Started: August 2012
Date Completion:
Last Updated: July 10, 2013
Last Verified: November 2012