Real-Time CAD for Colonic Neoplasia: A RCT

Riverside University Health System Medical Center

Status: Completed

Conditions: Colorectal Neoplasms; Colorectal Cancer

Treatments: Procedure: Stanford Colonoscopy; Device: Real-Time Computer Aided Detection

Study type: Interventional

Funder types: Other

Identifiers

NCT05963724

1922564-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 patients

Sex: All

Ages: 30 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Prior history of subtotal colectomy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,100 participants in 2 patient groups

Real-Time Computer Aided Detection

Experimental group

Treatment:

Device: Real-Time Computer Aided Detection

Standard Colonoscopy

Active Comparator group

Treatment:

Procedure: Stanford Colonoscopy