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Status unknownNCT00613262NBIUpdated Apr 9, 2012

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

An interventional study of Narrow Band Imaging in Colonoscopy, Adenomatous Polyp and Neoplastic, sponsored by Midwest Biomedical Research Foundation. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-09.

Sponsored by Midwest Biomedical Research Foundation · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colonoscopy
  • Adenomatous Polyp
  • Neoplastic

Keywords

  • Narrow Band Imaging
03

In context

Adenomatous Polyps

79 studies on the registry are indexed under Adenomatous Polyps; 9 are open to participants now.

This study's planned enrollment of 200 is close to the median of 208 across 52 interventional studies indexed under Adenomatous Polyps.

Browse Adenomatous Polyps studies →

Lead sponsor

Midwest Biomedical Research Foundation is the lead sponsor of 23 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • referral for screening or surveillance colonoscopy
  • the ability to provide informed consent

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
200 participants (estimated)

Interventions

  • OtherNarrow Band Imaging

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

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What researchers measure

Primary outcomes

  1. The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Kansas City VA Medical Center
    Kansas City, Missouri 64128, United States
    • Amit Rastogi, MD · Contact · amit.rastogi@va.gov · 816-861-4700
    • Amit Rastogi, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00613262
Lead sponsor
Midwest Biomedical Research Foundation
Responsible party
Amit Rastogi (Principal Investagator, Midwest Biomedical Research Foundation) — Principal investigator
First posted
Feb 13, 2008
Start date
Apr 2012
Primary completion
Nov 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Apr 9, 2012

Study contacts

Vikas Singh, MD, MHSA
Contact
vikas.singh@va.gov
816 861 4700 ext. 56428
Amit Rastogi, MD
principal investigator · Kansas City VA Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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