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Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

NCT05888623 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 334200

Last updated 2025-10-14

No results posted yet for this study

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

DEVICE

Computer Assisted Detection

Computer-assisted polyp detection system that utilizes artificial intelligence (AI) during colonoscopy

Sponsors & Collaborators

  • VA Salt Lake City Health Care System

    collaborator FED

  • San Francisco Veterans Affairs Medical Center

    collaborator FED

  • VA Puget Sound Health Care System

    lead FED

Principal Investigators

  • Jason A. Dominitz, MD, MHS · US Department of Veterans Affairs

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-06-30
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05888623 on ClinicalTrials.gov