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PR-0410: CLUE: CLinical Utility Study of EsoGuard

Sponsor
Lucid Diagnostics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06030180
Collaborator
(none)
500
Enrollment
8
Locations
1
Arm
7.2
Anticipated Duration (Months)
62.5
Patients Per Site
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: EsoGuard
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
Actual Study Start Date :
Feb 23, 2023
Anticipated Primary Completion Date :
Sep 29, 2023
Anticipated Study Completion Date :
Sep 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Single Arm Study

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)
Other Names:
  • EsoGuard test on cells collected using EsoCheck

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Utility [Through study completion, an average of 1 year]

      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. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.

    Secondary Outcome Measures

    1. Patient Compliance [Through study completion, an average of 1 year]

      Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results. This will be measured by collecting data on whether patients received an endoscopy after being referred.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.

    Exclusion Criteria:

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

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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Heartburn Treatment Center Heber Springs Arkansas United States 72543
    2 Arvada West Family Medicine, Arvada Colorado United States 80004
    3 Colorado Primary Healthcare Littleton Colorado United States 80120
    4 Savii Health Savannah Georgia United States 31406
    5 James E Race Dallas Texas United States 75224
    6 Texas Digestive Specialists Harlingen Texas United States 78550
    7 Gastroenterology Partners of North Houston, PLLC Shenandoah Texas United States 77384
    8 Premier Family Medical Lindon Utah United States 84042

    Sponsors and Collaborators

    • Lucid Diagnostics, Inc.

    Investigators

    • Study Director: Gisella Lopez, Lucid Diagnostics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lucid Diagnostics, Inc.
    ClinicalTrials.gov Identifier:
    NCT06030180
    Other Study ID Numbers:
    • PR-0410
    First Posted:
    Sep 8, 2023
    Last Update Posted:
    Sep 8, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Barrett Esophagus

    Study Results

    No Results Posted as of Sep 8, 2023