Computer Aided Detection of Polyps in Colonoscopy
Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
1 other identifier
interventional
1,472
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2021
CompletedFirst Submitted
Initial submission to the registry
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedDecember 1, 2021
November 1, 2021
9 months
February 10, 2021
November 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Adenoma detection rate
At the end of the procedure, 1 day
Sessile serrated lesions detected
At the end of the procedure, 1 day
Colorectal cancer surveillance interval
At the end of the procedure, 1 day
Study Arms (2)
Control
NO INTERVENTIONRoutine Colonoscopy
Experimental
EXPERIMENTALRoutine Colonoscopy with the use of Skout
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Iterative Scopes, Inclead
- University of Minnesotacollaborator
Study Sites (5)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Mount Auburn Hospital
Cambridge, Massachusetts, 02138, United States
MNGI Digestive Health
Plymouth, Minnesota, 55446, United States
Concord Endoscopy Center
Concord, New Hampshire, 03301, United States
Related Publications (1)
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.
PMID: 35643173DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aasma Shaukat, MD, MPH
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2021
First Posted
February 15, 2021
Study Start
January 22, 2021
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
December 1, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share