Adenoma, Colorectal (Colon or Rectal) Cancer
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEArtificial Intelligence Aided Colonoscopy (GI Genius™)
Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
DEVICEStandard Colonoscopy
Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope
DEVICECombined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
Subjects enrolled to arm 3 (AG) will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).
Sponsors
Smart Medical Systems Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients of age ≥ 45 years old 2. Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection) 3. The patient must understand and provide written consent for the procedure.
Exclusion criteria
1. Subjects with inflammatory bowel disease 2. Subjects with a personal history of polyposis syndrome 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy 4. Subjects with diverticulitis or toxic megacolon 5. Subjects with a history of radiation therapy to abdomen or pelvis 6. Pregnant or lactating female subjects 7. Subjects who are currently enrolled in another clinical investigation. 8. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 10. Any patient condition deemed too risky for the study by the investigator 11. Previous colonic surgery (except for appendectomy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Per Colonoscopy (APC) (AI compared with AG) | Upon histology results (up to 30 days) | Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Per Colonoscopy (APC) (SC compared with AG) | Upon histology results (up to 30 days) | Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG |
| Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG) | Upon histology results (up to 30 days) | Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG |
Countries
United States
Contacts
Primary ContactDouglas K Rex, MD
Outcome results
None listed