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

NCT05317351 | Unknown FDA Device

• 1 other identifier: G-EYE15080
• Study Type: interventional
• Target: 2,160
• Locations: 1 country
• Sites: 2

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

Conditions

Colorectal (Colon or Rectal) Cancer; Adenoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adenoma Per Colonoscopy (APC) (SC compared with AG)

  Upon histology results (up to 30 days)

• Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)

  Upon histology results (up to 30 days)

Study Arms (3)

Standard Colonoscopy ("SC")

ACTIVE COMPARATOR

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

Device: Standard Colonoscopy

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

ACTIVE COMPARATOR

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™)

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

EXPERIMENTAL

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

Interventions

Standard Colonoscopy DEVICE

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

Standard Colonoscopy ("SC")

Artificial Intelligence Aided Colonoscopy (GI Genius™) DEVICE

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

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

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

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

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Smart Medical Systems Ltd.: lead

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Douglad K Rex, MD

  Indina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas K Rex, MD

CONTACT

317-777-9676; drex@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 7, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)