Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

334200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Computer Assisted Detection

Colonoscopies performed at a VA facility with computer assisted detection (CADe) artificial intelligence available.

Computer Assisted Detection

Intervention Type DEVICE

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

Conventional Colonoscopy

Colonoscopies performed at a VA facility without CADe artificial intelligence available

No interventions assigned to this group

Interventions

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Computer Assisted Detection

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

Intervention Type DEVICE

Other Intervention Names

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GI Genius Intelligent Endoscopy Module (Medtronic)

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No