Spots Global Cancer Trial Database for To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age
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Trial Identification
Brief Title: To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age
Official Title: AIDA: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Artificial Intelligence (AI) Detection of Adenomas (AIDA) With Standard High Definition With Light in Screening Colonoscopy
Study ID: NCT04196088
Study Description
Brief Summary: The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.
Detailed Description:
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Gastro Health, Birmingham, Alabama, United States
Precision Research Institute, San Diego, California, United States
Kansas City Veterans Administration, Kansas City, Kansas, United States
Capital Digestive Care, Chevy Chase, Maryland, United States
East Side Endoscopy, New York, New York, United States
Great Lakes Gastroenterology Research, LLC, Clinical Trials Network, Mentor, Ohio, United States
Verity Research Inc., Gastro Health, Fairfax, Virginia, United States
Gastrointestinal & Liver Specialists of Tidewater, PLLC, Norfolk, Virginia, United States
Wisconsin GI Associates, Milwaukee, Wisconsin, United States
Contact Details
Name: Efren Rael, MD
Affiliation: Docbot, Inc.
Role: STUDY_DIRECTOR
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