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Efficacy of the Third Eye Retroscope Auxiliary Imaging System

NCT00657371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2013-12-09

Study results available
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Summary

The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope auxiliary imaging system.

The primary objective of this study is to assess the degree to which incorporating the Third Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the detection of additional polyps.

Specifically, the primary goals are to estimate (1) the proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope, and (2) the proportion of patients found under this protocol to have polyps who would have incorrectly been classified as polyp-free had the Third Eye Retroscope not been used.

Conditions

Interventions

DEVICE

Third Eye Retroscope Auxiliary Imaging System

A thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue.

Sponsors & Collaborators

  • Avantis Medical Systems

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Robert S. Bresalier, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00657371 on ClinicalTrials.gov