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NCT05963724 Clinical Trial

Real-Time CAD for Colonic Neoplasia: A RCT

Colorectal Cancer Clinical Trial

— CAD  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05963724
Other study ID # 1922564-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date May 27, 2023

Study information
Verified date July 2023
Source Riverside University Health System Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 1100
Est. completion date May 27, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 100 Years
Eligibility Inclusion Criteria: - Undergoing colonoscopy at RUHS - Age > 45 years - No contraindications to colonoscopy Exclusion Criteria: - Prior history of subtotal colectomy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Real-Time Computer Aided Detection
This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)
Procedure:
• Stanford Colonoscopy
This involves white-light colonoscopy

Locations
Country Name City State
United States Riverside University Health System Moreno Valley California

Sponsors (1)
Lead Sponsor Collaborator
Riverside University Health System Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Thiruvengadam NR, Cote GA, Gupta S, Rodrigues M, Schneider Y, Arain MA, Solaimani P, Serrao S, Kochman ML, Saumoy M. An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model. Gastroenterology. 2023 May;164(6):906-920. doi: 10.1053/j.gastro.2023.01.027. Epub 2023 Feb 2. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Adenoma Detection Rate 1 year
Secondary Adenomas Per Colon 1 year
Secondary Sessile Serrated Lesion Detection Rate 1 year
Secondary Sessile Serrated Lesions Per Colon 1 year
Secondary False Neoplasia Rate 1 year
Secondary Withdrawal Time 1 year
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