Colorectal Polyp
Conditions
Keywords
Screening Colonoscopy, Artificial Intelligence, Computer Aided Detection, Adenoma Detection Rate, Adenomas per Colonoscopy, Surveillance Colonoscopy, Colorectal Cancer, Software as a Medical Device
Brief summary
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.
Interventions
DEVICEComputer Aided Detection device
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.
Sponsors
University of Minnesota
Iterative Scopes, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenomas per colonoscopy | At the end of the procedure, 1 day | The total number of adenomas detected divided by the total number of colonoscopies. |
| Positive predictive value | At the end of the procedure, 1 day | The total number of adenomas and serrated lesions detected divided by the total number of extractions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | At the end of the procedure, 1 day | The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected. |
| Sessile serrated lesions detected | At the end of the procedure, 1 day | The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps. |
| Colorectal cancer surveillance interval | At the end of the procedure, 1 day | The mean recommended timeframe for follow up colonoscopy. |
Countries
United States
Outcome results
None listed