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
Status unconfirmed · Not applicable
Conditions studied: Colorectal Adenoma, Colorectal Polyp, Colorectal Adenocarcinoma, Colorectal SSA
In brief
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.
Key facts
- Study ID
- NCT04196088
- Run by
- Docbot, Inc.
- People needed
- 978
- Starts
- 2020-06-11
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2021-03-19
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: accepted.
Where it is running
- Gastro Health — Birmingham, Alabama, United States (enrolling)
- Precision Research Institute — San Diego, California, United States (enrolling)
- Kansas City Veterans Administration — Kansas City, Kansas, United States (enrolling)
- Capital Digestive Care — Chevy Chase, Maryland, United States (enrolling)
- East Side Endoscopy — New York, New York, United States (enrolling)
- Great Lakes Gastroenterology Research, LLC, Clinical Trials Network — Mentor, Ohio, United States (enrolling)
- Verity Research Inc., Gastro Health — Fairfax, Virginia, United States (enrolling)
- Gastrointestinal & Liver Specialists of Tidewater, PLLC — Norfolk, Virginia, United States (enrolling)
- Wisconsin GI Associates — Milwaukee, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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