NCT01372878

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 884 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• CRC Screening

Interventions

Type	Name	Description
DEVICE	PillCam® COLON 2 procedure	Subjects will undergo a PillCam® COLON 2 procedure which includes ingestion of the PillCam® COLON 2 capsule. PillCam® COLON 2 is a disposable, ingestible capsule that takes video images throughout the digestive system.
PROCEDURE	Colonoscopy	Subjects will undergo standard Colonoscopy procedure 4-6 weeks after PillCam® COLON 2 procedure. Standard colonoscopy involves placement of a standard endoscope (a thin, flexible plastic tube) into the anus and into the colon, a tiny camera in the endoscope allows the study doctor to see the surface of the colon.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-06-14
• Last updated: 2019-08-01
• Results posted: 2014-05-06

Locations

17 sites across 2 countries: United States, Israel