Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon

CRC Screening Clinical Trial

Official title: MA-204: Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon

Status Completed

Clinical Trial Summary

This study was design to establish the effectiveness of PillCam® Platform with the PillCam® COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to optical colonoscopy.

Clinical Trial Description

This multi-center study was designed to evaluate the safety and effectiveness of PillCam Platform with the PillCam COLON 2 capsule as demonstrated by the identification of subjects with polyps, compared to optical colonoscopy.

884 subjects participated in this study. All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps.

Each subject was required to follow a bowel preparation regimen and to undergo capsule endoscopy (CE) followed by optical colonoscopy (OC). The optical colonoscopy procedure was scheduled 4-6 weeks after CE procedure to allow for the central readers reading of the PillCam RAPID video.

The colonoscopist was kept blinded to the CE results ;

Related Conditions & MeSH terms

• CRC Screening

• NCT number: NCT01372878
• Study type: Interventional
• Source: Medtronic - MITG
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Completion date: June 2012