An observational study in Colorectal Neoplasms, sponsored by VA Puget Sound Health Care System. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by VA Puget Sound Health Care System · Observational
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 334,200 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →VA Puget Sound Health Care System is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Veterans undergoing colonoscopy for any indication at VA facilities across the United States.
Exclusion Criteria:
Colonoscopies performed at a VA facility with computer assisted detection (CADe) artificial intelligence available.
Device: Computer Assisted Detection
Colonoscopies performed at a VA facility without CADe artificial intelligence available
Computer-assisted polyp detection system that utilizes artificial intelligence (AI) during colonoscopy
Also known as: GI Genius Intelligent Endoscopy Module (Medtronic)
Adenoma Detection Rate
Change in the proportion of colonoscopies in which one or more adenomas are detected
Time frame: Baseline and 6 months
Adenocarcinoma detection rate
Change in the proportion of colonoscopies where colorectal cancer is detected
Time frame: Baseline and 6 months
Sessile serrated lesion detection rate
Proportion of colonoscopies with one or more sessile serrated lesions detected
Time frame: Baseline and 6 months
Proportion of colonoscopies with pathology obtained
Proportion of colonoscopies where specimens were obtained for pathologic review
Time frame: Baseline and 6 months
Proportion of pathology without adenoma or adenocarcinoma
As a surrogate for false positive lesion identification during use of CADe
Time frame: Baseline and 6 months
Withdrawal time without interventions
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: Baseline and 6 months
Provider satisfaction with computer assisted detection for colonoscopy
Provider ratings of satisfaction with the CADe device
Time frame: Approximately 6 months after deployment
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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VA Puget Sound Health Care System