Efficacy of the Third Eye Retroscope Auxiliary Imaging System

Completed · Not applicable

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00657371

Run by

M.D. Anderson Cancer Center

People needed

288

Starts

2008-03-01

Expected to finish

2010-05-01

Last updated by the study team

2013-12-09

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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