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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified


Screening


Active


18 and over


Other


AR0002
00371, NCT00613262

Trial Description

Summary

We 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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Veterans Affairs Medical Center - Kansas City

Midwest Biomedical Research Foundation

Amit Rastogi, MDPrincipal Investigator

Peggy J Callahan, RN MBAPh: 816 861 4700 Ext.56579
  Email: peggy.callahan@va.gov

Trial Sites

U.S.A.
Missouri
  Kansas City
 Veterans Affairs Medical Center - Kansas City
 Amit Rastogi, MD Ph: 816-861-4700 Ext.56725
  Email: amit.rastogi@va.gov
 Amit Rastogi, MDPrincipal Investigator
 Amit Rastogi, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00613262
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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