Clinical Evaluation of Narrow Band Imaging Colonoscope

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00628147
Recruitment Status : Completed
First Posted : March 4, 2008
Results First Posted : March 8, 2017
Last Update Posted : March 8, 2017
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System

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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Device: Narrow band imaging colonoscope Phase 4

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  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates
Study Start Date : January 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Neoplasm Miss Rate [ Time Frame: same day ]

Secondary Outcome Measures :
  1. Neoplasm Detection Rates [ Time Frame: same day ]
  2. Completion of Examinations [ Time Frame: same day ]
  3. Procedure Complications [ Time Frame: procedure and post-procedure complications within 30 days after colonoscopy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00628147

United States, California
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Principal Investigator: Roy Soetikno, MD, MS VA Palo Alto Health Care System

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Roy Soetikno, Clinical Professor, VA Palo Alto Health Care System Identifier: NCT00628147     History of Changes
Other Study ID Numbers: SOE0011
First Posted: March 4, 2008    Key Record Dates
Results First Posted: March 8, 2017
Last Update Posted: March 8, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Roy Soetikno, VA Palo Alto Health Care System:
colonic neoplasms
narrow band imaging
diagnostic techniques

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases