CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 884 enrolled
Drug / intervention
PillCam® COLON 2 procedure +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/NCT01372878
NCT01372878N/ACompleted

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

Medtronic - MITG·interventional·Posted Jun 14, 2011·Updated Aug 1, 2019

In Brief

A clinical study evaluating PillCam® COLON 2 procedure and Colonoscopy for CRC Screening. Completed, enrolled 884 participants across 17 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCRC Screening
CountriesIsrael, United States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2011
Enrollment StartJun 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.0 years ago

Interventions

PillCam® COLON 2 proceduredevice

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.

Colonoscopyprocedure

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.