A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®

Launched by SMART MEDICAL SYSTEMS LTD. · Mar 31, 2022

Keywords

ClinConnect 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 Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms.

Gender

ALL

Eligibility criteria

• 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)