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

NCT ID: NCT00613262

Last Updated: 2012-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy Adenomatous Polyp Neoplastic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Interventions

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Narrow Band Imaging

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Midwest Biomedical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Amit Rastogi

Principal Investagator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amit Rastogi, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City VA Medical Center

Locations

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Kansas City VA Medical Center

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vikas Singh, MD, MHSA

Role: CONTACT

816 861 4700 ext. 56428

Facility Contacts

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Amit Rastogi, MD

Role: primary

816-861-4700 ext. 56725

Other Identifiers

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00371

Identifier Type: -

Identifier Source: secondary_id

AR0002

Identifier Type: -

Identifier Source: org_study_id

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