search
Back to results

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

Primary Purpose

Colorectal (Colon or Rectal) Cancer, Adenoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Colonoscopy
Artificial Intelligence Aided Colonoscopy (GI Genius™)
Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
Sponsored by
Smart Medical Systems Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal (Colon or Rectal) Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Indiana University
  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Standard Colonoscopy ("SC")

Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Adenoma Per Colonoscopy (APC) (AI compared with AG)
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)
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)
Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG

Full Information

First Posted
March 31, 2022
Last Updated
March 31, 2022
Sponsor
Smart Medical Systems Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05317351
Brief Title
A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smart Medical Systems Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal (Colon or Rectal) Cancer, Adenoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 Colonoscopy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Colonoscopy ("SC")
Arm Type
Active Comparator
Arm Description
Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.
Arm Title
Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")
Arm Type
Active Comparator
Arm Description
Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
Arm Title
Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)
Arm Type
Experimental
Arm Description
Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Intervention Description
Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope
Intervention Type
Device
Intervention Name(s)
Artificial Intelligence Aided Colonoscopy (GI Genius™)
Intervention Description
Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
Intervention Type
Device
Intervention Name(s)
Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
Intervention Description
Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).
Primary Outcome Measure Information:
Title
Adenoma Per Colonoscopy (APC) (AI compared with AG)
Description
Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.
Time Frame
Upon histology results (up to 30 days)
Secondary Outcome Measure Information:
Title
Adenoma Per Colonoscopy (APC) (SC compared with AG)
Description
Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG
Time Frame
Upon histology results (up to 30 days)
Title
Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)
Description
Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG
Time Frame
Upon histology results (up to 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas K Rex, MD
Phone
317-777-9676
Email
drex@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglad K Rex, MD
Organizational Affiliation
Indina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas K Rex, MD
Phone
317-777-9676
Email
drex@iu.edu
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seth A Gross, MD
Phone
212-263-3095
Email
Seth.Gross@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs