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Clinical Evaluation of Narrow Band Imaging Colonoscope

Primary Purpose

Colonic Neoplasms

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Narrow band imaging colonoscope
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Neoplasms focused on measuring colonic neoplasms, colonoscopy, narrow band imaging, diagnostic techniques

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VAPaloAltoHCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Narrow band imaging colonoscope

White Light

Arm Description

narrow band imaging colonoscope

Conventional White Light Examination

Outcomes

Primary Outcome Measures

Neoplasm Miss Rate

Secondary Outcome Measures

Neoplasm Detection Rates
Completion of Examinations
Procedure Complications

Full Information

First Posted
February 25, 2008
Last Updated
January 17, 2017
Sponsor
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT00628147
Brief Title
Clinical Evaluation of Narrow Band Imaging Colonoscope
Official Title
Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
colonic neoplasms, colonoscopy, narrow band imaging, diagnostic techniques

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrow band imaging colonoscope
Arm Type
Experimental
Arm Description
narrow band imaging colonoscope
Arm Title
White Light
Arm Type
No Intervention
Arm Description
Conventional White Light Examination
Intervention Type
Device
Intervention Name(s)
Narrow band imaging colonoscope
Other Intervention Name(s)
CF-H180AL, CF-Q180AL, Evis Exera II CV-180
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neoplasm Miss Rate
Time Frame
same day
Secondary Outcome Measure Information:
Title
Neoplasm Detection Rates
Time Frame
same day
Title
Completion of Examinations
Time Frame
same day
Title
Procedure Complications
Time Frame
procedure and post-procedure complications within 30 days after colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Soetikno, MD, MS
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VAPaloAltoHCS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18523025
Citation
Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3.
Results Reference
derived

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Clinical Evaluation of Narrow Band Imaging Colonoscope

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