Efficacy of the Third Eye Retroscope Auxiliary Imaging System

This study has been completed.
Sponsor:
Collaborator:
Avantis Medical Systems
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00657371
First received: April 8, 2008
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
Device: Third Eye Retroscope Auxiliary Imaging System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER) [ Time Frame: Total 30 minutes procedure time with TER use. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 288
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657371

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
El Camino Hospital
Mountain View, California, United States, 94040
Camino Medical Group Surgi-Center
Sunnyvale, California, United States, 94086
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63130
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Avantis Medical Systems
Investigators
Principal Investigator: Robert S. Bresalier, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00657371     History of Changes
Other Study ID Numbers: 2007-0246
Study First Received: April 8, 2008
Results First Received: October 11, 2013
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Colorectal Cancer
Colonoscopy
Third Eye Retroscope
Third Eye Retroscope Auxiliary Imaging System
Polypectomy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 15, 2014