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

M

Midwest Biomedical Research Foundation

Status

Unknown

Conditions

Adenomatous Polyp
Colonoscopy
Neoplastic

Treatments

Other: Narrow Band Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT00613262
00371
AR0002

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Vikas Singh, MD, MHSA

Data sourced from clinicaltrials.gov

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