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

March 31, 2022 updated by: Smart Medical Systems Ltd.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Upon histology results (up to 30 days)
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)
Time Frame: Upon histology results (up to 30 days)
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)
Time Frame: 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
Upon histology results (up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smart Medical Systems Ltd.

Investigators

  • Principal Investigator: Douglad K Rex, MD, Indina University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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