Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1472 participants
INTERVENTIONAL
2021-01-22
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Control
Routine Colonoscopy
No interventions assigned to this group
Experimental
Routine Colonoscopy with the use of Skout
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Undergoing colonoscopy with screening, surveillance, or diagnostic indications.
* Undergoing a procedure by a participating endoscopist.
* Have given informed consent.
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Iterative Scopes, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Aasma Shaukat, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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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
Countries
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References
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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.
Other Identifiers
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Pro00047634
Identifier Type: -
Identifier Source: org_study_id