Clinical Evaluation of Narrow Band Imaging Colonoscope

This study has been completed.
Sponsor:
Information provided by:
VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT00628147
First received: February 25, 2008
Last updated: March 3, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Colonic Neoplasms
Device: Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates

Resource links provided by NLM:


Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • neoplasm miss rate [ Time Frame: same day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • neoplasm detection rates [ Time Frame: same day ] [ Designated as safety issue: No ]
  • completion of examinations [ Time Frame: same day ] [ Designated as safety issue: No ]
  • procedure complications [ Time Frame: procedure and post-procedure complications within 30 days after colonoscopy ] [ Designated as safety issue: Yes ]

Enrollment: 284
Study Start Date: January 2006
Study Completion Date: March 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
narrow band imaging colonoscope
Device: Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628147

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

No publications provided by VA Palo Alto Health Care System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roy Soetikno, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT00628147     History of Changes
Other Study ID Numbers: SOE0011
Study First Received: February 25, 2008
Last Updated: March 3, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 10, 2014