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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Device: Third Eye Retroscope

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.

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Evanston, Illinois, United States, 60201
      • Northshore University Healthsystem
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75235
      • Parkland Hospital
    • Fort Worth, Texas, United States, 76132
      • S.W. Fort Worth Endoscopy Center
    • North Richland Hills, Texas, United States, 76180
      • North Hills Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Third Eye Retroscope; All 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.	Device: Third Eye Retroscope; Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Spent During Withdrawal Phase and Total Procedure	Time in minutes for withdrawal phase of procedure and for total procedure	During the colonoscopy procedure (up to 1 hour, average 25 minutes)

Collaborators and Investigators

• Sponsor: Avantis Medical Systems
• Investigators: Principal Investigator: Daniel C DeMarco, MD, Baylor Health Care System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (ESTIMATE): September 1, 2009

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: polyps; colonoscopy; adenomas; miss rates
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Avantis TER 08-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO