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OpenTrials
Completed

NCT Number: NCT00628147

Clinical Evaluation of Narrow Band Imaging Colonoscope

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VAPaloAltoHCS

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrow band imaging colonoscope

Device

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

Primary outcomes

  1. Neoplasm Miss Rate

    Time frame: same day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 4, 2008
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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