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Study 8 of 11 for search of: | "Kansas City Veteran Affairs Medical Center" [Exact] |
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Sponsors and Collaborators: |
Kansas City Veteran Affairs Medical Center American Society for Gastrointestinal Endoscopy Midwest Biomedical Research Foundation |
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Information provided by: | Kansas City Veteran Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00614770 |
In this study the investigators hypothesize that narrow band imaging (NBI) will have a high accuracy in predicting polyp histology in real time during a colonoscopy by visualization of the surface mucosal and vascular patterns.
Specific Aim 1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy.
Specific Aim 2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns
Condition | Intervention |
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Adenomatous Polyp Neoplastic Polyp |
Procedure: standard of care colonoscopy Procedure: colonoscopy |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
Estimated Enrollment: | 630 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Standard White Light Colonoscopy
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Procedure: standard of care colonoscopy
Standard White Light Colonoscopy one exam per patient |
2: Experimental
High Definition White Light Colonoscopy
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Procedure: standard of care colonoscopy
High Definition White Light Colonoscopy one exam per patient |
3: Experimental
Narrow Band Imaging Colonoscopy
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Procedure: colonoscopy
Narrow Band Imaging Colonoscopy one exam per patient |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vikas Singh | 816 861 4700 ext 56428 | vikas.singh@va.gov |
United States, Missouri | |
Kansas City VA Medical Center | Recruiting |
Kansas City, Missouri, United States, 64128 |
Principal Investigator: | Amit Rastogi, MD | Kansas City VA Medical Center |
Responsible Party: | Kansas City VA Medical Center ( Amit Rastogi, MD ) |
Study ID Numbers: | AR0003, AR0003 |
Study First Received: | January 31, 2008 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00614770 |
Health Authority: | United States: Federal Government |
colonoscopy |
Pathological Conditions, Anatomical Colonic Polyps Polyps |
Adenoma Adenomatous Polyps Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type |