- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01354873
Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging
January 8, 2014 updated by: Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Information will be collected.
Images will be taken.
Study Type
Observational
Enrollment (Actual)
556
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Men and Women(not pregnant) presenting to the GI lab for colonoscopy.
Child bearing potential not excluded.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael B Wallace, MD,MPH, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
May 16, 2011
First Submitted That Met QC Criteria
May 16, 2011
First Posted (Estimate)
May 17, 2011
Study Record Updates
Last Update Posted (Estimate)
January 10, 2014
Last Update Submitted That Met QC Criteria
January 8, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10 002315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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