NCT00604162

PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To see if PillCam COLON will demonstrate diagnostic yield \>80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.

Detailed description

The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).

Conditions

• Colonic Diseases

Interventions

Type	Name	Description
DEVICE	PillCam COLON	The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.
PROCEDURE	Standard colonoscopy	Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2008-01-30
• Last updated: 2019-08-01
• Results posted: 2011-02-18

Locations

7 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom