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NCT00613262 Clinical Trial

A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging

Colonoscopy Clinical Trial

— NBI  

Official title:
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00613262
Other study ID # AR0002
Secondary ID 00371
Status Recruiting
Phase N/A
First received January 31, 2008
Last updated April 6, 2012
Start date April 2012
Est. completion date December 2013

Study information
Verified date February 2009
Source Midwest Biomedical Research Foundation
Contact Vikas Singh, MD, MHSA
Phone 816 861 4700
Email vikas.singh@va.gov
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Narrow Band Imaging
Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time

Locations
Country Name City State
United States Kansas City VA Medical Center Kansas City Missouri

Sponsors (1)
Lead Sponsor Collaborator
Midwest Biomedical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome
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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