Efficacy of the Third Eye Retroscope Auxiliary Imaging System
A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System
1 other identifier
interventional
288
1 country
7
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Mar 2008
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
December 9, 2013
CompletedDecember 9, 2013
October 1, 2013
2.2 years
April 8, 2008
October 11, 2013
October 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)
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.
Total 30 minutes procedure time with TER use.
Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)
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.
Total 30 minutes procedure time with TER use.
Secondary Outcomes (1)
Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.
2 year study period to collect colonoscopy exam results
Study Arms (1)
Third Eye Retroscope
EXPERIMENTALColonoscopy exam using the Third Eye Retroscope device
Interventions
A thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Avantis Medical Systemscollaborator
Study Sites (7)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
El Camino Hospital
Mountain View, California, 94040, United States
Camino Medical Group Surgi-Center
Sunnyvale, California, 94086, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University
St Louis, Missouri, 63130, United States
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.
PMID: 20018280RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert S. Bresalier, MD / Professor
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Robert S. Bresalier, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 14, 2008
Study Start
March 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
December 9, 2013
Results First Posted
December 9, 2013
Record last verified: 2013-10