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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Midwest Biomedical Research Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Amit Rastogi, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT00613262
First received: January 31, 2008
Last updated: April 6, 2012
Last verified: February 2009
  Purpose

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.


Condition Intervention
Colonoscopy
Adenomatous Polyp
Neoplastic
Other: Narrow Band Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging

Resource links provided by NLM:


Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:
  • The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Narrow Band Imaging
    Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613262

Contacts
Contact: Vikas Singh, MD, MHSA 816 861 4700 ext 56428 vikas.singh@va.gov

Locations
United States, Missouri
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: Amit Rastogi, MD    816-861-4700 ext 56725    amit.rastogi@va.gov   
Principal Investigator: Amit Rastogi, MD         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Investigators
Principal Investigator: Amit Rastogi, MD Kansas City VA Medical Center
  More Information

No publications provided

Responsible Party: Amit Rastogi, Principal Investagator, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT00613262     History of Changes
Other Study ID Numbers: AR0002, 00371
Study First Received: January 31, 2008
Last Updated: April 6, 2012
Health Authority: United States: Federal Government

Keywords provided by Midwest Biomedical Research Foundation:
Narrow Band Imaging

Additional relevant MeSH terms:
Polyps
Adenomatous Polyps
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014