Computer Aided Detection of Polyps in Colonoscopy

Completed · Not applicable

Conditions studied: Colorectal Polyp

In brief

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.

Key facts

Study ID

NCT04754347

Run by

Iterative Scopes, Inc

People needed

1472

Starts

2021-01-22

Expected to finish

2021-10-31

Last updated by the study team

2021-12-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Mount Auburn Hospital — Cambridge, Massachusetts, United States
• MNGI Digestive Health — Plymouth, Minnesota, United States
• Concord Endoscopy Center — Concord, New Hampshire, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.