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

Completed

• Conditions: Pediatrics, Colon Capsule Endoscopy

• Registration Number: NCT01740349
• Lead Sponsor: Azienda Policlinico Umberto I

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 Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-09
• Status Verified: 2012-11
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Study Completion: 2013-02
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sapienza - University of Rome; 🇮🇹 Rome, Italy