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

This study is currently recruiting participants.

Verified February 2009 by Midwest Biomedical Research Foundation

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

History of Changes

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:

MedlinePlus related topics: Colonic Polyps Colonoscopy

U.S. FDA Resources

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:

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

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:

Colonic Polyps
Polyps
Adenomatous Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013

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