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

April 6, 2012 updated by: Amit Rastogi, Midwest Biomedical Research Foundation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Recruiting
        • Kansas City VA Medical Center
        • Contact:
        • Principal Investigator:
          • Amit Rastogi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Biomedical Research Foundation

Investigators

  • Principal Investigator: Amit Rastogi, MD, Kansas City VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2012

Last Update Submitted That Met QC Criteria

April 6, 2012

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR0002
  • 00371

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy

Clinical Trials on Narrow Band Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe