Impact of Experience on Results With the Third Eye Retroscope

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avantis Medical Systems
ClinicalTrials.gov Identifier:
NCT00969124
First received: August 27, 2009
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Colorectal Neoplasia
Device: Third Eye Retroscope

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy

Resource links provided by NLM:


Further study details as provided by Avantis Medical Systems:

Primary Outcome Measures:
  • Detection rates for adenomas and for all polyps by the Third Eye Retroscope in comparison to the standard colonoscope alone [ Time Frame: The study is an acute study only. The utility of the device will be assessed from immediate (peri-procedural) clinical outcomes of patients enrolled into the study and from 24-72 hour telephone follow-up to assess for post-procedural complications. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time spent during the withdrawal phase and total procedure time for colonoscopy using the Third Eye Retroscope [ Time Frame: The study is an acute study only. The duration of procedural time intervals will be determined during the procedures performed on study patients. ] [ Designated as safety issue: No ]

Enrollment: 328
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Third Eye Retroscope Device: Third Eye Retroscope
Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy

Detailed Description:

Purpose: This study is intended to determine characteristics of the "learning curve" for use of the Third Eye Retroscope during colonoscopy, both in terms of efficacy for detection of abnormalities in the colon and time-efficiency for endoscopists

Device Description: The Third Eye Retroscope is an auxiliary imaging device that is designed to allow visualization of "hidden areas" during colonoscopy by providing an additional, retrograde view that complements the forward view of the colonoscope.

After a standard colonoscope has been advanced to the cecum, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As it emerges from the distal tip of the colonoscope, the Third Eye Retroscope automatically bends 180 degrees to form a "J" shape. Its sensor then provides a continuous retrograde view of the colon throughout the process of withdrawal of the colonoscope.

The retrograde view assists the endoscopist in visualizing the proximal aspect of haustral folds and rectal valves, as well as the areas behind flexures and the ileocecal valve. With this additional point-of-view, the endoscopist may be able to detect lesions that can be missed by the forward-viewing colonoscope.

Study Design: Patients who are scheduled for colonoscopy will be recruited to the study and examined with the Third Eye Retroscope in conjunction with a standard colonoscope. For each polyp that is found, the endoscopist will indicate whether it could be seen with the colonoscope, or if it could be found with the colonoscope only because it was first detected with the Third Eye.

Each investigator will perform colonoscopies on 20 patients, who will be segmented into four quartiles according to the order of their procedures. Mean results for the quartiles will be compared in order to evaluate the learning curve for Third Eye colonoscopy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
  2. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

  1. Patients with a history of colonic resection;
  2. Patients with inflammatory bowel disease;
  3. Patients with a personal history of polyposis syndrome;
  4. Patients with suspected chronic stricture potentially precluding complete colonoscopy;
  5. Patients with diverticulitis or toxic megacolon;
  6. Patients with a history of radiation therapy to abdomen or pelvis.
  7. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969124

Locations
United States, Florida
Florida Hospital
Celebration, Florida, United States, 34747
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Parkland Hospital
Dallas, Texas, United States, 75235
S.W. Fort Worth Endoscopy Center
Fort Worth, Texas, United States, 76132
North Hills Hospital
North Richland Hills, Texas, United States, 76180
Sponsors and Collaborators
Avantis Medical Systems
Investigators
Principal Investigator: Daniel C DeMarco, MD Baylor Health Care System
  More Information

Publications:
Responsible Party: Avantis Medical Systems
ClinicalTrials.gov Identifier: NCT00969124     History of Changes
Other Study ID Numbers: Avantis TER 08-07
Study First Received: August 27, 2009
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Avantis Medical Systems:
colonoscopy
polyps
adenomas
miss rates

ClinicalTrials.gov processed this record on October 23, 2014