CLUE: CLinical Utility Study of EsoGuard

Last updated: June 24, 2025
Sponsor: Lucid Diagnostics, Inc.
Overall Status: Completed

Phase

N/A

Condition

Esophageal Disorders

Treatment

EsoGuard

Clinical Study ID

NCT06030180
PR-0410
  • Ages 12-99
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG

  2. Individuals who meet criteria for BE screening in accordance with either the 2022ACG guidelines, or the AGA best practice advice from their 2022 clinical practiceupdate.

Exclusion

Exclusion Criteria:

  1. Individuals who fall outside the eligible population defined by the EsoCheck deviceInstructions For Use (IFU)

  2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BEscreening

  3. Inability to provide written informed consent or participate in the required followup

Study Design

Total Participants: 566
Treatment Group(s): 1
Primary Treatment: EsoGuard
Phase:
Study Start date:
February 23, 2023
Estimated Completion Date:
December 13, 2024

Connect with a study center

  • Arkansas Heartburn Treatment Center

    Heber Springs, Arkansas 72543
    United States

    Site Not Available

  • Arvada West Family Medicine,

    Arvada, Colorado 80004
    United States

    Site Not Available

  • Colorado Primary Healthcare

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Savii Health

    Savannah, Georgia 31406
    United States

    Site Not Available

  • James E Race

    Dallas, Texas 75224
    United States

    Site Not Available

  • Texas Digestive Specialists

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Gastroenterology Partners of North Houston, PLLC

    Shenandoah, Texas 77384
    United States

    Site Not Available

  • Premier Family Medical

    Lindon, Utah 84042
    United States

    Site Not Available

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