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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||556 participants|
|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|
- 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.
- 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.
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
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Michael B Wallace, MD,MPH||Mayo Clinic Florida|