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| Sponsored by: |
VA Palo Alto Health Care System |
|---|---|
| Information provided by: | VA Palo Alto Health Care System |
| ClinicalTrials.gov Identifier: | NCT00628147 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
| Official Title: | Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates |
| 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 |
|---|---|
|
1: Experimental
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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| VAPaloAltoHCS | |
| Palo Alto, California, United States, 94304 | |
| Principal Investigator: | Roy Soetikno, MD, MS | VA Palo Alto Health Care System |
More Information
| Responsible Party: | VA Palo Alto Health Care System ( Roy Soetikno ) |
| Study ID Numbers: | SOE0011 |
| Study First Received: | February 25, 2008 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00628147 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
colonic neoplasms colonoscopy narrow band imaging diagnostic techniques |
|
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |
|
Neoplasms Neoplasms by Site |
