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

NCT01372878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 884

Last updated 2019-08-01

Study results available
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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.

Conditions

  • CRC Screening

Interventions

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.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Douglas Rex, Prof. · Indiana University Hospital, Indianapolis, IN, USA

Study Design

Allocation
NA
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372878 on ClinicalTrials.gov