Purpose

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.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Control
Routine Colonoscopy
Experimental
Experimental
Routine Colonoscopy with the use of Skout
  • Device: Computer 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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Daniel Chung, MD
Chung.Daniel@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Iterative Scopes, Inc

Study Contact

Sloane A Phillips, MBA
(617) 487-2349
sloane.phillips@iterativescopes.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.