Recruiting

Narrow Band Imaging

Sponsor:

Midwest Biomedical Research Foundation

Code:

NCT00613262

Conditions

Colonoscopy

Adenomatous Polyp

Neoplastic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Narrow Band Imaging

Study Details

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.

Conditions

Colonoscopy

Adenomatous Polyp

Neoplastic

Study ID

NCT00613262

Start date

Apr, 2012

Status verified date

Feb, 2009

Completion date

Dec, 2013

Anticipated

Primary completion date

Nov, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

Narrow Band Imaging

Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time

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 ]

Central Contacts and Locations

Central contacts

Vikas Singh, MD, MHSA

816 861 4700vikas.singh@va.gov

Locations

Kansas City VA Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

Amit Rastogi, MD

816-861-4700amit.rastogi@va.gov

Principal Investigator:

Amit Rastogi, MD

More Information

Sponsor

Midwest Biomedical Research Foundation

Last update posted

Apr 9, 2012

Last verified

Feb, 2009

Keywords

  • Narrow Band Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Midwest Biomedical Research Foundation on 2012-04-09.