A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System
50 Years
80 Years
Both
Colorectal Cancer
Trial Information
A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System
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.
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.
Type of Study:
Interventional
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:
No
Principal Investigator
Robert S. Bresalier, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2007-0246
NCT ID:
NCT00657371
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
Name | Location |
|---|---|
| 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 |
