Clinical Evaluation of Narrow Band Imaging Colonoscope

January 17, 2017 updated by: Roy Soetikno, VA Palo Alto Health Care System

Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates

The purpose of the study is to determine if colonoscopic examination using a colonoscope with a narrow band imaging light is more effective at detecting polyps compared to a colonoscope with standard full spectrum white light.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a clinical study to evaluate whether the use of a new type of colonoscope may improve the detection of colon polyps. Though colonoscopy is currently the best test for colon cancer screening, it remains imperfect. Research has found that about 25% of polyps may actually be missed during colonoscopy using standard full spectrum white light imaging. Advances in colonoscopic technology hold the potential to decrease the miss rate of colorectal neoplasms. A new colonoscope uses narrow band imaging, whereby the colon is illuminated using only a subset of the white light spectrum, 415nanometers (blue) and 540 nanometers (green) rather than the standard full spectrum white light (red, green and blue). Initial studies by other groups suggest that these narrow band images highlight small blood vessels of colon polyps. As such, we hypothesized that the use of NBI would improve the identification of neoplasms through the color differentiation of precancerous or cancerous polyp (appearing brown) from normal colon mucosal lining (appearing green), and potentially lead to a reduction in polyp miss rate. We aimed to study the polyp miss rate, and compare narrow band imaging to white light examination.

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 4

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

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • VAPaloAltoHCS

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • referred for elective outpatient colonoscopy

Exclusion Criteria:

  • known inflammatory bowel disease
  • personal or family history of polyposis syndrome
  • referral for resection of a known lesion

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narrow band imaging colonoscope
narrow band imaging colonoscope
Device: Narrow band imaging colonoscope
Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
Other Names:
  • CF-H180AL
  • CF-Q180AL
  • Evis Exera II CV-180
No Intervention: White Light
Conventional White Light Examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neoplasm Miss Rate
Time Frame: same day
same day

Secondary Outcome Measures

Outcome Measure
Time Frame
Neoplasm Detection Rates
Time Frame: same day
same day
Completion of Examinations
Time Frame: same day
same day
Procedure Complications
Time Frame: procedure and post-procedure complications within 30 days after colonoscopy
procedure and post-procedure complications within 30 days after colonoscopy

Collaborators and Investigators

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

Sponsor

VA Palo Alto Health Care System

Investigators

  • Principal Investigator: Roy Soetikno, MD, MS, VA Palo Alto Health Care System

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

January 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

March 3, 2008

First Posted (Estimate)

March 4, 2008

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOE0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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