NCT05888623

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 334,200 (actual)
• Sponsor: VA Puget Sound Health Care System · Federal
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	Computer Assisted Detection	Computer-assisted polyp detection system that utilizes artificial intelligence (AI) during colonoscopy

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2023-06-05
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study