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

NCT ID: NCT05317351

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-12-31

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.

Conditions

Colorectal (Colon or Rectal) Cancer; Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Standard Colonoscopy ("SC")

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

Group Type: ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type: DEVICE

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

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™)

Group Type: ACTIVE_COMPARATOR

Artificial Intelligence Aided Colonoscopy (GI Genius™)

Intervention Type: DEVICE

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

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™).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

Standard Colonoscopy

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

Intervention Type: 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™)

Intervention Type: 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™).

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Smart Medical Systems Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglad K Rex, MD

Role: PRINCIPAL_INVESTIGATOR

Indina University

Locations

Indiana University

Indianapolis, Indiana, United States

NYU Langone Health

New York, New York, United States

Countries

United States

Central Contacts

Douglas K Rex, MD

Role: CONTACT

drex@iu.edu

317-777-9676

Facility Contacts

Douglas K Rex, MD

Role: primary

drex@iu.edu

317-777-9676

Seth A Gross, MD

Role: primary

Seth.Gross@nyulangone.org

212-263-3095

Other Identifiers

G-EYE15080

Identifier Type: -

Identifier Source: org_study_id