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AI Colorectal Polyp Detection

NCT04979962 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1162

Last updated 2023-09-18

No results posted yet for this study

Summary

This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.

Conditions

  • Polyp Colorectal
  • Adenoma Colon

Interventions

DEVICE

EW10-EC02 (Endoscopy Support Program)

EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.

Sponsors & Collaborators

  • Fujifilm Medical Systems USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Prateek Sharma, MD · Kansas City VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2022-09-30
Completion
2022-11-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04979962 on ClinicalTrials.gov