Colon Polyps Clinical Trial
Official title:
Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging
Verified date | January 2014 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 556 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Olympic Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of In Vivo determination of colorectal polyps histopathology | 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. | 1 year | No |
Secondary | Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes. | 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. | 1 year | No |
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