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Clinical Trials/NCT05963724
NCT05963724
Completed
Not Applicable

Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial

Riverside University Health System Medical Center1 site in 1 country1,100 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Riverside University Health System Medical Center
Enrollment
1100
Locations
1
Primary Endpoint
Adenoma Detection Rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
May 27, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Undergoing colonoscopy at RUHS
  • Age \> 45 years
  • No contraindications to colonoscopy

Exclusion Criteria

  • Prior history of subtotal colectomy

Outcomes

Primary Outcomes

Adenoma Detection Rate

Time Frame: 1 year

Secondary Outcomes

  • False Neoplasia Rate(1 year)
  • Sessile Serrated Lesions Per Colon(1 year)
  • Sessile Serrated Lesion Detection Rate(1 year)
  • Withdrawal Time(1 year)
  • Adenomas Per Colon(1 year)

Study Sites (1)

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