Computer Aided Detection of Polyps in Colonoscopy

Study Overview
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Brief Summary
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The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.

Official Title
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Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy

Conditions
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Colorectal Polyp

Intervention / Treatment
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* Device: Computer Aided Detection device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Participants will be eligible for this study if they are: Undergoing colonoscopy with screening, surveillance, or diagnostic indications. Undergoing a procedure by a participating endoscopist. Have given informed consent. Exclusion Criteria Participants will not be eligible for this study if they: Have a history of inflammatory bowel disease. Have a history of familial adenomatous polyposis. Are under the age of 40. Have had a colonoscopy within the previous three (3) years. Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test. Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator). Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Routine Colonoscopy | |
| Experimental: Experimental<br>Routine Colonoscopy with the use of Skout | Device: Computer Aided Detection device<br>* The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenomas per colonoscopy | The total number of adenomas detected divided by the total number of colonoscopies. | At the end of the procedure, 1 day | 
| Positive predictive value | The total number of adenomas and serrated lesions detected divided by the total number of extractions. | At the end of the procedure, 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected. | At the end of the procedure, 1 day | 
| Sessile serrated lesions detected | The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps. | At the end of the procedure, 1 day | 
| Colorectal cancer surveillance interval | The mean recommended timeframe for follow up colonoscopy. | At the end of the procedure, 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening Colonoscopy, Artificial Intelligence, Computer Aided Detection, Adenoma Detection Rate, Adenomas per Colonoscopy, Surveillance Colonoscopy, Colorectal Cancer, Software as a Medical Device