Kansas City, Missouri 64128


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.


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


Study is Available At:


Original ID:

AR0002


NCT ID:

NCT00613262


Secondary ID:

00371


Study Acronym:

NBI


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Midwest Biomedical Research Foundation


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Amit Rastogi, MD
Principal Investigator
Kansas City VA Medical Center
Primary Contact:Vikas Singh, MD, MHSA
816 861 4700 ext. 56428
816 861 4700
vikas.singh@va.gov

Study Dates

Start Date:April 2012
Completion Date:December 2013
Completion Type:Anticipated
Primary Completion Date:November 2013
Primary Completion Type:Anticipated
Verification Date:February 2009
Last Changed Date:April 6, 2012
First Received Date:January 31, 2008

Study Outcomes

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

Study Interventions

Intervention Type:Other
Name:Narrow Band Imaging
Description:Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Midwest Biomedical Research Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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