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Artificial Intelligence

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

N/A
Waitlist Available
Led By Douglad K Rex, MD
Research Sponsored by Smart Medical Systems Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon histology results (up to 30 days)
Awards & highlights

Summary

This trial compares three methods of performing a colonoscopy to see which one finds more abnormal growths. The methods include a standard procedure, one with computer assistance, and one with both computer assistance and a special balloon. The goal is to find out which method is best at detecting growths that could lead to cancer.

Eligible Conditions
  • Colorectal Cancer
  • Adenoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon histology results (up to 30 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon histology results (up to 30 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adenoma Per Colonoscopy (APC) (AI compared with AG)
Secondary outcome measures
Adenoma Per Colonoscopy (APC) (SC compared with AG)
Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)Experimental Treatment1 Intervention
Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).
Group II: Standard Colonoscopy ("SC")Active Control1 Intervention
Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.
Group III: Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")Active Control1 Intervention
Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)

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Who is running the clinical trial?

Smart Medical Systems Ltd.Lead Sponsor
8 Previous Clinical Trials
2,066 Total Patients Enrolled
Douglad K Rex, MDPrincipal InvestigatorIndina University
~648 spots leftby Sep 2025
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