CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 332 enrolled
Drug / intervention
PillCam COLON +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00604162
NCT00604162Phase 3Completed
CompareCT.gov

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

Medtronic - MITG·interventional·Posted Jan 30, 2008·Updated Aug 1, 2019

In Brief

A Phase 3 clinical trial evaluating PillCam COLON and Standard colonoscopy for Colonic Diseases. Completed, enrolled 332 participants across 7 sites in 5 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonic Diseases
CountriesFrance, Germany, Italy, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartOct 1, 2006
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.4 years ago

Interventions

PillCam COLONdevice

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.

Standard colonoscopyprocedure

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.