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

50 Years
80 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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


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.


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.


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope

Outcome Time Frame:

2 year study period to collect colonoscopy exam results

Safety Issue:


Principal Investigator

Robert S. Bresalier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

May 2010

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer
  • Colonoscopy
  • Third Eye Retroscope
  • Third Eye Retroscope Auxiliary Imaging System
  • Polypectomy
  • Colorectal Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624
El Camino Hospital Mountain View, California  94040
Indiana University Medical Center Indianapolis, Indiana  46202
Washington University St. Louis, Missouri  63110
U.T.M.D. Anderson Cancer Center Houston, Texas  77030
Mayo Clinic Scottsdale, Arizona  
Camino Medical Group Surgi-Center Sunnyvale, California  94086