VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
NCT Number: NCT05888623
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.
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Observational
Seattle, Washington, 98108, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Computer-assisted polyp detection system that utilizes artificial intelligence (AI) during colonoscopy
Other names: GI Genius Intelligent Endoscopy Module (Medtronic)
Time frame: Baseline and 6 months
Change in the proportion of colonoscopies in which one or more adenomas are detected
Time frame: Baseline and 6 months
Change in the proportion of colonoscopies where colorectal cancer is detected
Time frame: Baseline and 6 months
Proportion of colonoscopies with one or more sessile serrated lesions detected
Time frame: Baseline and 6 months
Proportion of colonoscopies where specimens were obtained for pathologic review
Time frame: Baseline and 6 months
As a surrogate for false positive lesion identification during use of CADe
Time frame: Baseline and 6 months
Change in the duration of colonoscope withdrawal when no intervention (e.g., polypectomy, biopsy) is performed. This outcome can only be assessed at a subset of sites due to data availability issues (i.e., Provation MD sites).
Time frame: Approximately 6 months after deployment
Provider ratings of satisfaction with the CADe device
VA Puget Sound Health Care System
Fed
Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)
Acronym: CADeNCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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