Clinical Evaluation of Narrow Band Imaging Colonoscope
Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates
1 other identifier
interventional
284
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 4, 2008
CompletedResults Posted
Study results publicly available
March 8, 2017
CompletedMarch 8, 2017
January 1, 2017
1.1 years
February 25, 2008
January 17, 2017
January 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neoplasm Miss Rate
same day
Secondary Outcomes (3)
Neoplasm Detection Rates
same day
Completion of Examinations
same day
Procedure Complications
procedure and post-procedure complications within 30 days after colonoscopy
Study Arms (2)
Narrow band imaging colonoscope
EXPERIMENTALnarrow band imaging colonoscope
White Light
NO INTERVENTIONConventional White Light Examination
Interventions
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.
Eligibility Criteria
You may qualify if:
- referred for elective outpatient colonoscopy
You may not qualify if:
- known inflammatory bowel disease
- personal or family history of polyposis syndrome
- referral for resection of a known lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VAPaloAltoHCS
Palo Alto, California, 94304, United States
Related Publications (1)
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. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3.
PMID: 18523025DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tonya Kaltenbach
- Organization
- SF VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Soetikno, MD, MS
VA Palo Alto Health Care System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 4, 2008
Study Start
January 1, 2006
Primary Completion
February 1, 2007
Study Completion
March 1, 2007
Last Updated
March 8, 2017
Results First Posted
March 8, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share