Efficacy of the Third Eye Retroscope Auxiliary Imaging System
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

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.
    

Intervention name(s): Third Eye Retroscope Auxiliary Imaging System
Intervention type(s): Device
Intervention description(s): A thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colorectal Cancer; Colonoscopy; Third Eye Retroscope; Third Eye Retroscope Auxiliary Imaging System; Polypectomy