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