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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Colonoscopy ("SC") | Active Comparator | Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope. |
|
| Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI") | Active Comparator | Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™) |
|
| Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG) | Experimental | Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Colonoscopy | Device | Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Per Colonoscopy (APC) (AI compared with AG) | Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG. | Upon histology results (up to 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Per Colonoscopy (APC) (SC compared with AG) | Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG | Upon histology results (up to 30 days) |
| Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Douglas K Rex, MD | Contact | 317-777-9676 | drex@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Douglad K Rex, MD | Indina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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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™), and (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
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| Artificial Intelligence Aided Colonoscopy (GI Genius™) | Device | Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™) |
|
| Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy | Device | Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™). |
|
Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG |
| Upon histology results (up to 30 days) |
| NYU Langone Health | New York | New York | 10016 | United States |
|
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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