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

NCT05317351 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2160

Last updated 2022-04-07

No results posted yet for this study

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

Interventions

DEVICE

Standard Colonoscopy

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

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™)

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™).

Sponsors & Collaborators

  • Smart Medical Systems Ltd.

    lead INDUSTRY

Principal Investigators

  • Douglad K Rex, MD · Indina University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05317351 on ClinicalTrials.gov