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Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

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ClinicalTrials.gov Identifier: NCT01354873
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : January 10, 2014
Sponsor:
Collaborator:
Olympic Medical
Information provided by:
Mayo Clinic

Brief Summary:
The investigators seek to compare the accuracy of the existing colonoscope model to determine the magnitude of the improvement the investigators can expect in polyp discrimination as neoplastic or non-neoplastic.

Condition or disease
Colon Polyps

Detailed Description:
Information will be collected. Images will be taken.

Study Type : Observational
Actual Enrollment : 556 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging
Study Start Date : January 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps
U.S. FDA Resources




Primary Outcome Measures :
  1. Accuracy of In Vivo determination of colorectal polyps histopathology [ Time Frame: 1 year ]
    Compare accuracy of current colonoscope to improved colonoscope for discrimination of polyps as neoplastic versus non-neoplastic. The accuracies of the two approaches will be compared via logistic regression model with the significance of the difference in the accuracies assessed via generalized estimating equation approach to take account of the possible dependence introduced by inclusion of mulitple polyps per patient.


Secondary Outcome Measures :
  1. Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes. [ Time Frame: 1 year ]
    Estimate the sensitivity and specificity in high definition mode for distinguishing neoplastic from none neoplastic lesions. Sensitivity and specificity will be estimated using the logistic regression approach as above; 95% confidence intervals will be obtained by transforming confidence intervals on the logs odds scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and Women(not pregnant) presenting to the GI lab for colonoscopy. Child bearing potential not excluded.
Criteria

Inclusion Criteria:

  • Age 18 and older
  • Presenting for surveillance, screening or diagnostic colonoscopy
  • Willingness to provide informed consent

Exclusion Criteria:

  • Inability to provided informed consent
  • Pregnancy
  • Known inflammatory bowel disease
  • Personal or family history of polyposis or nonpolyposis syndrome
  • Emergency colonoscopy/endoscopy
  • Coagulopathy or thrombocytopenia preventing polypectomy
  • Procedure indication for acute bleeding or active colitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354873


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Olympic Medical
Investigators
Principal Investigator: Michael B Wallace, MD,MPH Mayo Clinic Florida

Responsible Party: Michael B Wallace, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01354873     History of Changes
Other Study ID Numbers: 10 002315
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014

Keywords provided by Mayo Clinic:
Colonoscopy
Colon Polyps

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps