Computer Aided Detection of Polyps in Colonoscopy

Iterative Scopes

Status

Completed

Conditions

Colorectal Polyp

Treatments

Device: Computer Aided Detection device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04754347

Pro00047634

Details and patient eligibility

About

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.

Enrollment

1,472 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.