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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
978
Screening Colonoscopy
Screening Colonoscopy
Gastro Health
Birmingham, Alabama, United States
RECRUITINGPrecision Research Institute
San Diego, California, United States
RECRUITINGKansas City Veterans Administration
Kansas City, Kansas, United States
RECRUITINGCapital Digestive Care
Chevy Chase, Maryland, United States
RECRUITINGEast Side Endoscopy
New York, New York, United States
RECRUITINGGreat Lakes Gastroenterology Research, LLC, Clinical Trials Network
Mentor, Ohio, United States
RECRUITINGVerity Research Inc., Gastro Health
Fairfax, Virginia, United States
RECRUITINGGastrointestinal & Liver Specialists of Tidewater, PLLC
Norfolk, Virginia, United States
RECRUITINGWisconsin GI Associates
Milwaukee, Wisconsin, United States
RECRUITINGOverall adenoma detection, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
The primary efficacy endpoint is the mean adenomas per colonoscopy procedure (MAP) detection, as defined by the protocol, with Ultivision AI software enhancement to screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time frame: through study completion, an average of 1 year
Overall adenomas per extraction, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard hiigh definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
The primary safety endpoint is the adenomas per extraction per colonoscopy procedure (APE), as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus SHDWLC without AI.
Time frame: through study completion, an average of 1 year
Adenoma detection rate, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
The secondary efficacy endpoint is the adenoma detection rate (ADR) defined as the ratio of screening colonoscopies with at least one adenoma, as defined by the protocol, detected divided by the total number of screening SHDWLC performed with Ultivision AI versus screening SHDWLC performed without AI.
Time frame: through study completion, an average of 1 year
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