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OpenTrials
Completed

NCT Number: NCT05888623

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer Assisted Detection

Device

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

Other names: GI Genius Intelligent Endoscopy Module (Medtronic)

Primary outcomes

  1. Adenoma Detection Rate

    Time frame: Baseline and 6 months

    Change in the proportion of colonoscopies in which one or more adenomas are detected

Secondary outcomes

  1. Adenocarcinoma detection rate

    Time frame: Baseline and 6 months

    Change in the proportion of colonoscopies where colorectal cancer is detected

  2. Sessile serrated lesion detection rate

    Time frame: Baseline and 6 months

    Proportion of colonoscopies with one or more sessile serrated lesions detected

  3. Proportion of colonoscopies with pathology obtained

    Time frame: Baseline and 6 months

    Proportion of colonoscopies where specimens were obtained for pathologic review

  4. Proportion of pathology without adenoma or adenocarcinoma

    Time frame: Baseline and 6 months

    As a surrogate for false positive lesion identification during use of CADe

  5. Withdrawal time without interventions

    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).

  6. Provider satisfaction with computer assisted detection for colonoscopy

    Time frame: Approximately 6 months after deployment

    Provider ratings of satisfaction with the CADe device

Sponsors and collaborators

Lead sponsor

VA Puget Sound Health Care System

Fed

Collaborators

  • San Francisco Veterans Affairs Medical Center
  • VA Salt Lake City Health Care System

Registry information

Official study title

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

Acronym: CADeNCE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2023
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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