Colonoscopy Clinical Trial
— NBIOfficial title:
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. 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. Aim#2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - referral for screening or surveillance colonoscopy - the ability to provide informed consent Exclusion Criteria: - prior surgical resection of any portion of colon - prior history of colon cancer - history of inflammatory bowel disease - use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure - poor general condition or any other reason to avoid prolonged procedure time - history of polyposis syndrome or Hereditary Non-polyposis colon cancer - inability to give informed consent |
Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Kansas City VA Medical Center | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Midwest Biomedical Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome. | 1 year | No |
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