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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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