An interventional study of Standard Colonoscopy and Artificial Intelligence Aided Colonoscopy (GI Genius™) in Colorectal (Colon or Rectal) Cancer and Adenoma, sponsored by Smart Medical Systems Ltd.. Status unknown at 2 sites in United States. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Smart Medical Systems Ltd. · Not applicable, Interventional, and Screening
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.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's planned enrollment of 2,160 is above the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Smart Medical Systems Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.
Device: Standard Colonoscopy
Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)
Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).
Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
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™).
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)
Plan to share: No
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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