A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
NBI
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 9, 2012
February 1, 2009
1.6 years
January 31, 2008
April 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.
1 year
Interventions
Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time
Eligibility Criteria
You may qualify if:
- referral for screening or surveillance colonoscopy
- the ability to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Rastogi, MD
Kansas City VA Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investagator
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
April 1, 2012
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
April 9, 2012
Record last verified: 2009-02