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Clinical Evaluation of Narrow Band Imaging Colonoscope
This study has been completed.
Study NCT00628147   Information provided by VA Palo Alto Health Care System
First Received: February 25, 2008   Last Updated: March 3, 2008   History of Changes

February 25, 2008
March 3, 2008
January 2006
February 2007   (final data collection date for primary outcome measure)
neoplasm miss rate [ Time Frame: same day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00628147 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Clinical Evaluation of Narrow Band Imaging Colonoscope
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.

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.

Phase IV
Interventional
Diagnostic, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Colonic Neoplasms
Device: Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180)
Experimental: narrow band imaging colonoscope
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. Epub 2008 Jun 3.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
284
March 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00628147
Roy Soetikno, VA Palo Alto Health Care System
SOE0011
VA Palo Alto Health Care System
 
Principal Investigator: Roy Soetikno, MD, MS VA Palo Alto Health Care System
VA Palo Alto Health Care System
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP