search
Back to results

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

Primary Purpose

Colonoscopy, Adenomatous Polyp, Neoplastic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrow Band Imaging
Sponsored by
Midwest Biomedical Research Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonoscopy focused on measuring Narrow Band Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kansas City VA Medical CenterRecruiting

Outcomes

Primary Outcome Measures

The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2008
Last Updated
April 6, 2012
Sponsor
Midwest Biomedical Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00613262
Brief Title
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
Acronym
NBI
Official Title
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwest Biomedical Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Adenomatous Polyp, Neoplastic
Keywords
Narrow Band Imaging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Narrow Band Imaging
Intervention Description
Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time
Primary Outcome Measure Information:
Title
The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vikas Singh, MD, MHSA
Phone
816 861 4700
Ext
56428
Email
vikas.singh@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Rastogi, MD
Organizational Affiliation
Kansas City VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Rastogi, MD
Phone
816-861-4700
Ext
56725
Email
amit.rastogi@va.gov
First Name & Middle Initial & Last Name & Degree
Amit Rastogi, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs