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CLUE: CLinical Utility Study of EsoGuard

NCT06030180 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2025-06-27

No results posted yet for this study

Summary

Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.

Conditions

  • Barrett Esophagus
  • Barretts Esophagus With Dysplasia
  • Esophagus Adenocarcinoma

Interventions

DEVICE

EsoGuard

EsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1)

Sponsors & Collaborators

  • Lucid Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Gisella Lopez · Lucid Diagnostics

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-23
Primary Completion
2024-12-13
Completion
2024-12-13
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 NCT06030180 on ClinicalTrials.gov