Impact of Experience on Results With the Third Eye Retroscope
Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy
1 other identifier
interventional
328
1 country
9
Brief Summary
The Third Eye Retroscope is a device that can be used with a colonoscope to improve the ability of a physician to see areas of the colon that may be hidden from the view of the colonoscope. Previous studies have shown that physicians are able to detect additional polyps when they use the device along with the colonoscope. The purpose of this study is to determine whether physicians can detect greater numbers of additional polyps as they gain in experience with the device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Shorter than P25 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 27, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
July 26, 2017
CompletedJuly 26, 2017
June 1, 2017
9 months
August 27, 2009
July 18, 2016
June 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Detection Rates for Adenomas
Adenomas detected with the colonoscope alone vs. with the Retroscope
During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Detection Rates for All Polyps
All polyps detected with the colonoscope alone vs. with the Retroscope
During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Secondary Outcomes (1)
Time Spent During Withdrawal Phase and Total Procedure
During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Study Arms (1)
Third Eye Retroscope
EXPERIMENTALAll subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Interventions
Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy
Eligibility Criteria
You may qualify if:
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- The patient must understand and provide written consent for the procedure.
You may not qualify if:
- Patients with a history of colonic resection;
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- Patients with diverticulitis or toxic megacolon;
- Patients with a 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
Study Sites (9)
Florida Hospital
Celebration, Florida, 34747, United States
University of Chicago
Chicago, Illinois, 60637, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Parkland Hospital
Dallas, Texas, 75235, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
S.W. Fort Worth Endoscopy Center
Fort Worth, Texas, 76132, United States
North Hills Hospital
North Richland Hills, Texas, 76180, United States
Related Publications (1)
DeMarco DC, Odstrcil E, Lara LF, Bass D, Herdman C, Kinney T, Gupta K, Wolf L, Dewar T, Deas TM, Mehta MK, Anwer MB, Pellish R, Hamilton JK, Polter D, Reddy KG, Hanan I. Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group. Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.
PMID: 20189513RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No randomization or blinding and no separate control group. Determinations regarding adequacy of bowel cleansing and whether each polyp could have been detected with the colonoscope alone involved a judgement by the endoscopist.
Results Point of Contact
- Title
- Jack Higgins, MD - Chief Medical Officer
- Organization
- Avantis Medical Systems , Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel C DeMarco, MD
Baylor Health Care System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2009
First Posted
September 1, 2009
Study Start
January 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
July 26, 2017
Results First Posted
July 26, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share