Expired Study
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Palo Alto, California 94304


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.


Study summary:

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.


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


Study is Available At:


Original ID:

SOE0011


NCT ID:

NCT00628147


Secondary ID:


Study Acronym:


Brief Title:

Clinical Evaluation of Narrow Band Imaging Colonoscope


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Palo Alto Health Care System


Oversight Authority:

  • United States: Federal Government
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

284


Enrollment Type:

Actual


Overall Contact Information

Official Name:Roy Soetikno, MD, MS
Principal Investigator
VA Palo Alto Health Care System

Study Dates

Start Date:January 2006
Completion Date:March 2007
Completion Type:Actual
Primary Completion Date:February 2007
Primary Completion Type:Actual
Verification Date:February 2008
Last Changed Date:March 3, 2008
First Received Date:February 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:neoplasm miss rate
Time Frame:same day
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:neoplasm detection rates
Time Frame:same day
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:completion of examinations
Time Frame:same day
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:procedure complications
Time Frame:procedure and post-procedure complications within 30 days after colonoscopy
Safety Issues:True

Study Interventions

Intervention Type:Device
Name:Narrow band imaging colonoscope (CF-H180AL, CF-Q18
Description: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.
Arm Name:1
Other Name:CF-H180AL

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:narrow band imaging colonoscope

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Palo Alto Health Care System

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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