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Clinical Trials/NCT01354873
NCT01354873
Completed
Not Applicable

Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Mayo Clinic1 site in 1 country556 target enrollmentJanuary 2011
ConditionsColon Polyps

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colon Polyps
Sponsor
Mayo Clinic
Enrollment
556
Locations
1
Primary Endpoint
Accuracy of In Vivo determination of colorectal polyps histopathology
Status
Completed
Last Updated
12 years ago

Overview

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.

Detailed Description

Information will be collected. Images will be taken.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
August 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes.(1 year)

Study Sites (1)

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