This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
2,160
Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope
Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).
Indiana University
Indianapolis, Indiana, United States
NYU Langone Health
New York, New York, United States
Adenoma Per Colonoscopy (APC) (AI compared with AG)
Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.
Time frame: Upon histology results (up to 30 days)
Adenoma Per Colonoscopy (APC) (SC compared with AG)
Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG
Time frame: Upon histology results (up to 30 days)
Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)
Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG
Time frame: Upon histology results (up to 30 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.