Status:
COMPLETED
Efficacy of the Third Eye Retroscope Auxiliary Imaging System
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Avantis Medical Systems
Conditions:
Colorectal Cancer
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief 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 t...
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 miniatu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00657371
Start Date
March 1 2008
End Date
May 1 2010
Last Update
December 9 2013
Active Locations (7)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
El Camino Hospital
Mountain View, California, United States, 94040
3
Camino Medical Group Surgi-Center
Sunnyvale, California, United States, 94086
4
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202