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• To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age

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  Unknown statusInterventionalNot ApplicableUpdated Mar 19, 2021

ClinicalTrials.gov ID

NCT05317351

Lead Sponsor

Smart Medical Systems Ltd.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

2,160Estimated

Last Update Posted

Apr 7, 2022Actual

Start Date

May 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

Official Title

A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy ("SC"), (ii) Artificial Intelligence (GI Genius™) ("AI"), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy

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.

• Colorectal (Colon or Rectal) Cancer
• Adenoma

• Standard Colonoscopy
• Artificial Intelligence Aided Colonoscopy (GI Genius™)
• Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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)

Primary Purpose

Screening

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Smart Medical Systems Ltd.INDUSTRY

Seth.Gross@nyulangone.org212-263-3095