Third Eye Retroscope Randomized Clinical Evaluation (TERRACE)

June 26, 2017 updated by: Avantis Medical Systems

Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)

The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone.

Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first.

Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colonoscopy is generally agreed to be the best method for detecting and removing pre-cancerous polyps, but some lesions can be missed, especially if they are located behind folds in the lining of the colon or behind flexures (sharp bends) in the colon.

The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon. Previous studies have shown the device to be effective for detecting additional polyps that could not have been seen with the colonoscope alone.

The purpose of this research is to compare the additional diagnostic yield obtained by using the Third Eye® Retroscope® vs. the diagnostic yield for the standard colonoscope alone in the context of a randomized, controlled study design.

Patients who are scheduled for colonoscopy will be recruited to the study and randomized to one of two groups. Each patient will undergo two "back-to-back" procedures.

Patients in Group A (study group) will undergo a standard colonoscopy followed immediately by a Third Eye colonoscopy.

Patients in Group B (control group) will undergo a Third Eye colonoscopy followed immediately by a standard colonoscopy.

Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.

Study Type

Interventional

Enrollment (Actual)

448

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1200
        • Cliniques Universitaires Saint-Luc
  • Italy
      • Milan, Italy, 20089 Rozzano
        • Istituto Clinico Humanitas
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • United Kingdom
      • London, United Kingdom, HA1 3UJ
        • St. Mark's Hospital
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City Veterans Administration Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Bayside Endoscopy Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A - COLO, then TER
Complete examination with standard colonoscope ("COLO") followed by complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope
Device: Third Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon
ACTIVE_COMPARATOR: Group B - TER, then COLO
Complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope, followed by complete examination with standard colonoscope ("COLO") alone
Device: Third Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection Rates for Adenomas and for Total Polyps
Time Frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.
Numbers of polyps and adenomas detected in first and second procedures for each group
Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Times for Withdrawal Phase and for Complete Procedure
Time Frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.
For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure
Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avantis Medical Systems

Investigators

  • Principal Investigator: Peter D. Siersema, MD, PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (ESTIMATE)

January 8, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 25, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Avantis TER-08-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregated, de-identified data to be published in peer-reviewed medical journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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