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

Not Applicable

• Conditions: Colorectal (Colon or Rectal) Cancer; Adenoma
• Interventions: Device: Standard Colonoscopy; Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy; Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)

• Registration Number: NCT05317351
• Lead Sponsor: Smart Medical Systems Ltd.

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.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Study Start: 2022-05
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Colonoscopy ("SC")	Standard Colonoscopy	Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.
Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)	Combined 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™).
Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")	Artificial Intelligence Aided Colonoscopy (GI Genius™)	Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

NYU Langone Health; 🇺🇸 New York, New York, United States