NCT01044732

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
5 countries

9 active sites

Status
completed

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

March 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

October 1, 2015

Completed
Last Updated

July 25, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

January 6, 2010

Results QC Date

August 28, 2015

Last Update Submit

June 26, 2017

Conditions

Colorectal Neoplasms

Keywords

ColorectalNeoplasmsAdenomasPolypsMiss ratesDetection ratesColonoscopeThird Eye Retroscope

Outcome Measures

Primary Outcomes (1)

  • Detection Rates for Adenomas and for Total Polyps

    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 Outcomes (1)

  • Times for Withdrawal Phase and for Complete Procedure

    Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.

Study Arms (2)

Group A - COLO, then TER

EXPERIMENTAL

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

Group B - TER, then COLO

ACTIVE COMPARATOR

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

Interventions

Third Eye RetroscopeDEVICE

Device used with colonoscope to provide second, retrograde view of the colon

Group A - COLO, then TERGroup B - TER, then COLO

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Kansas City Veterans Administration Medical Center

Kansas City, Missouri, 64128, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Bayside Endoscopy Center

Providence, Rhode Island, 02905, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, B-1200, Belgium

Location

Istituto Clinico Humanitas

Milan, 20089 Rozzano, Italy

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

St. Mark's Hospital

London, HA1 3UJ, United Kingdom

Location

Related Publications (2)

  • Leufkens AM, DeMarco DC, Rastogi A, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, Siersema PD; Third Eye Retroscope Randomized Clinical Evaluation [TERRACE] Study Group. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc. 2011 Mar;73(3):480-9. doi: 10.1016/j.gie.2010.09.004. Epub 2010 Nov 10.

    PMID: 21067735RESULT

  • Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.

    PMID: 22807609RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasmsAdenomaPolyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Limitations and Caveats

With mean subject age of 57.8 years, population was younger than in some studies, so polyp prevalence might be below average.

Results Point of Contact

Title
Jack Higgins, MD - Chief Medical Officer
Organization
Avantis Medical Systems
jhiggins@avantismedical.com
6508239216

Study Officials

  • Peter D. Siersema, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 8, 2010

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

July 25, 2017

Results First Posted

October 1, 2015

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

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

Locations

GB(1)BE(1)US(5)IT(1)NL(1)