Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

VA Puget Sound Health Care System

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Device: Computer Assisted Detection

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT05888623

VHA_NGHP_001

Details and patient eligibility

About

The goal of this cluster randomized study is to determine if artificial intelligence systems used during colonoscopy can improve the detection of precancerous polyps in the colon. The primary question it aims to answer is whether computer-assisted detection devices improve the proportion of colonoscopies found to have precancerous adenomatous polyps.

Secondary aims will assess if computer-assisted detection devices improve the proportion of colonoscopies found to other types of precancerous polyps known as sessile serrated lesions, or cancer of the colon and rectum. The study will also assess possible negative effects of use of computer-assisted detection (e.g., prolonging the procedure time or false-positive biopsies) and survey device users to learn about their experience with this technology.

The study team will provide computer-assisted detection devices to randomly chosen VA medical centers for use during colonoscopy and compare colonoscopy findings for patients who undergo colonoscopy at facilities that are equipped with these devices to the findings of patients who undergo colonoscopy at VA facilities that do not have these devices.

A survey will be distributed to physicians who perform colonoscopy to assess their experience using computer-assisted detection devices.

Enrollment: 334,200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colonoscopy performed at a Veterans Affairs (VA) medical center

Exclusion criteria

• Colonoscopy performed at VA medical centers that acquired computer-assisted detection artificial intelligence devices through non-random assignment
• Colonoscopy performed at a VA medical center where pathology results are not available

Trial design

334,200 participants in 2 patient groups

Computer Assisted Detection

Description:

Colonoscopies performed at a VA facility with computer assisted detection (CADe) artificial intelligence available.

Treatment:

Device: Computer Assisted Detection

Conventional Colonoscopy

Description:

Colonoscopies performed at a VA facility without CADe artificial intelligence available