Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

Study Overview
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Brief Summary
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Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.

Official Title
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Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

Conditions
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Colon Cancer

Intervention / Treatment
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* Other: Colometer
* Other: Sham Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: patients categorized as normal risk who have been referred for screening colonoscopy at the Forzani & MacPhail Colon Cancer Screening Centre in Calgary, Alberta Endoscopists: Gastroenterologists with practices at the Forzani & MacPhail Colon Cancer Screening Centre, Calgary, Alberta Exclusion Criteria: Patients: patients who are not categorized as normal risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colometer<br>Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist. | Other: Colometer<br>* Real time software based image analysis tool.<br>|
| Sham Comparator: Sham Software<br>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<br>* Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.<br>|
| No Intervention: Control<br>Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %Clear | 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. | Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average withdrawal velocity |  | Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes. | 
| Ottawa Stool Score |  | Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, quality assurance