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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Adenoma; Colorectal (Colon or Rectal) Cancer
• Intervention / Treatment: Device: Standard Colonoscopy; Device: Artificial Intelligence Aided Colonoscopy (GI Genius™); Device: 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 Type: Interventional
• Enrollment (Anticipated): 2160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Douglas K Rex, MD; Phone Number: 317-777-9676; Email: drex@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
      • Contact: Douglas K Rex, MD; Phone Number: 317-777-9676; Email: drex@iu.edu
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
      • Contact: Seth A Gross, MD; Phone Number: 212-263-3095; Email: Seth.Gross@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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™).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Per Colonoscopy (APC) (AI compared with AG)	Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.	Upon histology results (up to 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Per Colonoscopy (APC) (SC compared with AG)	Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG	Upon histology results (up to 30 days)
Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)	Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG	Upon histology results (up to 30 days)

Collaborators and Investigators

• Sponsor: Smart Medical Systems Ltd.
• Investigators: Principal Investigator: Douglad K Rex, MD, Indina University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (ACTUAL): April 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: G-EYE15080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No