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

Sponsor

Smart Medical Systems Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05317351

Collaborator

(none)

2,160

Enrollment

Locations

Arms

Anticipated Duration (Months)

1080

Patients Per Site

153.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal (Colon or Rectal) Cancer Adenoma	Device: Standard Colonoscopy Device: Artificial Intelligence Aided Colonoscopy (GI Genius™) Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 ColonoscopyThis 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

Masking:

None (Open Label)

Primary Purpose:

Screening

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Colonoscopy ("SC") Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.	Device: Standard Colonoscopy Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope
Active Comparator: Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI") Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)	Device: Artificial Intelligence Aided Colonoscopy (GI Genius™) Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
Experimental: Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG) Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).	Device: 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™).

Arm

Intervention/Treatment

Active Comparator: Standard Colonoscopy ("SC")

Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.

Device: Standard Colonoscopy

Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope

Active Comparator: Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")

Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)

Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)

Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)

Experimental: Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)

Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).

Device: 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™).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients of age ≥ 45 years old
Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection)
The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

Subjects with inflammatory bowel disease
Subjects with a personal history of polyposis syndrome
Subjects with suspected chronic stricture potentially precluding complete colonoscopy
Subjects with diverticulitis or toxic megacolon
Subjects with a history of radiation therapy to abdomen or pelvis
Pregnant or lactating female subjects
Subjects who are currently enrolled in another clinical investigation.
Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
Any patient condition deemed too risky for the study by the investigator
Previous colonic surgery (except for appendectomy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46202
2	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

Smart Medical Systems Ltd.

Investigators

Principal Investigator: Douglad K Rex, MD, Indina University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Smart Medical Systems Ltd.

ClinicalTrials.gov Identifier:

NCT05317351

Other Study ID Numbers:

G-EYE15080

First Posted:

Apr 7, 2022

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Adenoma

Study Results

No Results Posted as of Apr 7, 2022