Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01969292|
Recruitment Status : Terminated (Stage 1 Complete; Stage 2 and 3 not pursued)
First Posted : October 25, 2013
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Other: Colometer Other: Sham Software||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist.
Real time software based image analysis tool.
Sham Comparator: Sham Software
An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy.
Other: Sham Software
Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.
No Intervention: Control
Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software.
- %Clear [ Time Frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes ]This is defined as the Percentage of the total withdrawal time where the withdrawal velocity is below a set speed limit and the view is clear (ie, not blurry) as measured by the software. Visualization of the colon lumen is ideal with a slow, non-blurry view in order to detect polyps.
- Average withdrawal velocity [ Time Frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes. ]
- Ottawa Stool Score [ Time Frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes. ]
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): NCT01969292
|Forzani&MacPhail Colon Cancer Screening Centre|
|Calgary, Alberta, Canada, T2N 4Z6|
|Principal Investigator:||Christopher N Andrews, MD MSc||University of Calgary|