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Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population

NCT05778851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-10-30

Study results available
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Summary

This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.

The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).

After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.

Conditions

  • Barrett Esophagus

Interventions

DEVICE

EsoGuard result

Education slide-set EsoGuard and patient cases including EsoGuard result

Sponsors & Collaborators

  • Medex15

    collaborator INDUSTRY

  • Lucid Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Victoria T Lee, MD · Lucid Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2024-07-31
Completion
2024-08-19
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05778851 on ClinicalTrials.gov