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Real-Time CAD for Colonic Neoplasia: A RCT

Not Applicable
Completed
Conditions
Colorectal Cancer
Colorectal Neoplasms
Interventions
Procedure: Stanford Colonoscopy
Device: Real-Time Computer Aided Detection
Registration Number
NCT05963724
Lead Sponsor
Riverside University Health System Medical Center
Brief Summary

This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Detailed Description

Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1100
Inclusion Criteria
  • Undergoing colonoscopy at RUHS
  • Age > 45 years
  • No contraindications to colonoscopy
Exclusion Criteria
  • Prior history of subtotal colectomy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard ColonoscopyStanford Colonoscopy-
Real-Time Computer Aided DetectionReal-Time Computer Aided Detection-
Primary Outcome Measures
NameTimeMethod
Adenoma Detection Rate1 year
Secondary Outcome Measures
NameTimeMethod
Withdrawal Time1 year
Adenomas Per Colon1 year
Sessile Serrated Lesions Per Colon1 year
Sessile Serrated Lesion Detection Rate1 year
False Neoplasia Rate1 year

Trial Locations

Locations (1)

Riverside University Health System

🇺🇸

Moreno Valley, California, United States

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