Narrow Band Imaging Colon Polyp Study
NCT00614770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 630
Last updated 2010-06-17
Summary
In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy.
Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI.
Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI.
Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure.
Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns
Conditions
- Adenomatous Polyp
- New Imaging Techniques in Colonoscopy
Interventions
- PROCEDURE
-
standard of care colonoscopy
Standard White Light Colonoscopy one exam per patient
- PROCEDURE
-
colonoscopy
Narrow Band Imaging Colonoscopy one exam per patient
- PROCEDURE
-
standard of care colonoscopy
High Definition White Light Colonoscopy one exam per patient
Sponsors & Collaborators
-
American Society for Gastrointestinal Endoscopy
collaborator OTHER -
Midwest Biomedical Research Foundation
collaborator OTHER -
Kansas City Veteran Affairs Medical Center
lead FED
Principal Investigators
-
Amit Rastogi, MD · Kansas City VA Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-11-30
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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