Efficacy of the Third Eye Retroscope Auxiliary Imaging System

October 11, 2013 updated by: M.D. Anderson Cancer Center

A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

THE STUDY DEVICE:

The Third Eye Retroscope is a thin, flexible probe that can be inserted in a standard colonoscope in order to display very detailed images of the colon tissue. It contains a miniature video camera that allows the doctor to see an additional point of view that looks backward while the regular colonoscope and study device are moved together through the length of the colon.

For you to be eligible to take part in this study, your doctor will check to be sure you have no medical conditions that would increase your risk of having any complications as a result of having the study device used during your colonoscopy.

STUDY PROCEDURES:

If you are found to be eligible to take part in this study, your doctor will perform your colonoscopy exam in the usual manner except that the Third Eye Retroscope device will be used during the exam as well. Your doctor will insert the colonoscope into your rectum in the usual manner and will then insert the study device down a channel inside the colonoscope. You will sign a separate consent form for the colonoscopy, which will describe the procedure and its risks in more detail.

During the exam, you will be awake. If you have chosen to use medications for conscious sedation, you will be drowsy.

FOLLOW-UP PHONE CALL:

About 48 hours (2 days) after the study procedure, you will be called by the research staff to see how you are doing. After this follow-up call, your participation in this study will be over.

This is an investigational study. The Third Eye Retroscope device is commercially available, but it is not FDA approved for this study's purpose. At this time, for this purpose, it is being used in research only. Up to 700 patients will take part in this study. Up to 100 will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Mountain View, California, United States, 94040
        • El Camino Hospital
      • Sunnyvale, California, United States, 94086
        • Camino Medical Group Surgi-Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • St. Louis, Missouri, United States, 63130
        • Washington University
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient is undergoing colonoscopy for screening purposes or for surveillance in follow-up for previous polypectomy.
  • The patient is at satisfactory risk for abdominal surgery.
  • The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

  • Patients who are <50 years or >80 years of age
  • Patients who are pregnant.
  • Patients with history of colonic resection.
  • Patients requiring ongoing anticoagulation therapy.
  • Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.
  • Patients with hypersensitivity to opioid analgesics.
  • Patients with an active systemic infection.
  • Patients with suspected chronic stricture potentially precluding complete colonoscopy.
  • Patients with major psychiatric disease (dementia, schizophrenia or depression).
  • Patients with diverticulitis or toxic megacolon.
  • Patients with history of radiation therapy to abdomen or pelvis.
  • Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Third Eye Retroscope
Colonoscopy exam using the Third Eye Retroscope device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)
Time Frame: Total 30 minutes procedure time with TER use.
After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
Total 30 minutes procedure time with TER use.
Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)
Time Frame: Total 30 minutes procedure time with TER use.
After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
Total 30 minutes procedure time with TER use.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.
Time Frame: 2 year study period to collect colonoscopy exam results
Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total.
2 year study period to collect colonoscopy exam results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Avantis Medical Systems

Investigators

  • Principal Investigator: Robert S. Bresalier, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0246

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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