Computer Aided Detection of Polyps in Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Polyp
• Intervention / Treatment: Device: Computer Aided Detection device

• Study Type: Interventional
• Enrollment (Actual): 1472
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Cambridge, Massachusetts, United States, 02138
      • Mount Auburn Hospital
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • MNGI Digestive Health
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
      • Concord Endoscopy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Iterative Scopes, Inc
• Collaborators: University of Minnesota
• Investigators: Principal Investigator: Aasma Shaukat, MD, MPH, University of Minnesota

Publications and helpful links

General Publications

• Shaukat A, Lichtenstein DR, Somers SC, Chung DC, Perdue DG, Gopal M, Colucci DR, Phillips SA, Marka NA, Church TR, Brugge WR; SKOUT Registration Study Team. Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. 2022 Sep;163(3):732-741. doi: 10.1053/j.gastro.2022.05.028. Epub 2022 May 25.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2021
• Primary Completion (ACTUAL): October 31, 2021
• Study Completion (ACTUAL): October 31, 2021

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (ACTUAL): February 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Artificial Intelligence; Adenoma Detection Rate; Screening Colonoscopy; Surveillance Colonoscopy; Computer Aided Detection; Adenomas per Colonoscopy; Software as a Medical Device
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: Pro00047634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No