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Trial record 1 of 1 for:    EG-CL-101
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Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE (ESOGUARDBE1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04293458
Recruitment Status : Completed
First Posted : March 3, 2020
Last Update Posted : January 25, 2023
Information provided by (Responsible Party):
PAVmed Inc. ( Lucid Diagnostics, Inc. )

Brief Summary:
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Esophageal Adenocarcinoma Barretts Esophagus With Dysplasia Barrett's Esophagus Without Dysplasia Device: EsoGuard Not Applicable

Detailed Description:
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, Single Arm
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Multicenter, Single-Arm Study of the Efficacy of EsoGuard(TM) on Samples Collected Using EsoCheck(TM) Versus Esophagogastroduodenoscopy for the Diagnosis of Barrett's Esophagus in an At-Risk Screening Population
Actual Study Start Date : February 28, 2020
Actual Primary Completion Date : August 22, 2022
Actual Study Completion Date : August 22, 2022

Arm Intervention/treatment
Experimental: EsoCheck vs. EGD with or without biopsies
All subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies)
Device: EsoGuard
EsoGuard assay (LDT) will be used on cells collected using EsoCheck (510K cleared esophageal cell collection device) and compared to results of EGD plus biopsies (when taken)

Primary Outcome Measures :
  1. Primary Efficacy [ Time Frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks ]
    The sensitivity and specificity of EsoGuard for the diagnosis of BE on samples collected using EsoCheck, wherein the definitive diagnosis of BE is made by concomitant EGD and biopsy.

Secondary Outcome Measures :
  1. Secondary Efficacy [ Time Frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks ]
    Negative predictive value (NPV) and positive predictive value (PPV), calculated for the observed prevalence and over a range of prevalences from 1 to 15%.

Other Outcome Measures:
  1. Safety of EsoCheck device administration [ Time Frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks ]
    Assessed by evaluation of AEs/SAEs/ADEs/SADEs/USADEs and Medical Device Deficiency Incidents

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Men aged 50 years old and older
  2. ≥5 years either of

    • GERD symptoms,
    • GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or,
    • any combination of treated and untreated periods, as long the cumulative total is at least 5 years
  3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
  4. One or more of the following risk factors:

    1. Caucasian race
    2. Current or past history of cigarette smoking
    3. BMI of at least 30 kg/m2
    4. First-degree relative with BE or EAC


Exclusion Criteria:

  1. History of prior EGD procedure
  2. Inability to provide written informed consent
  3. On anti-coagulant drug(s) that cannot be temporarily discontinued
  4. Known history of esophageal varices or esophageal stricture
  5. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
  6. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  7. Oropharyngeal tumor
  8. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
  9. History of myocardial infarction or cerebrovascular accident within past 6 months
  10. History of esophageal motility disorder
  11. Currently implanted Linx device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293458

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United States, California
Lucid Investigative Site
Orange, California, United States, 92868
United States, Colorado
Lucid Investigative Site
Englewood, Colorado, United States, 80113
United States, Florida
Lucid Investigative Site
Naples, Florida, United States, 34102
Lucid Investigative Site
Palm Harbor, Florida, United States, 34684
United States, Georgia
Lucid Investigative Site
Macon, Georgia, United States, 31201
United States, Idaho
Lucid Investigative Site
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Lucid Investigative Site
Rockford, Illinois, United States, 61107
United States, Louisiana
Lucid Investigative Site
New Orleans, Louisiana, United States, 70112
Lucid Investigative Site
Shreveport, Louisiana, United States, 71105
United States, Michigan
Lucid Investigative Site
Wyoming, Michigan, United States, 49519
United States, Mississippi
Lucid Investigative Site
Flowood, Mississippi, United States, 39232
United States, Nebraska
Lucid Investigative Site
Omaha, Nebraska, United States, 68124
United States, New York
Lucid Investigative Site
New York, New York, United States, 10016
Lucid Investigative Site
Rochester, New York, United States, 14620
United States, North Carolina
Lucid Investigative Site
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
Lucid Investigative Site
Oklahoma City, Oklahoma, United States, 73102
United States, Pennsylvania
Lucid Investigative Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Lucid Investigative Site
Greenville, South Carolina, United States, 29615
United States, Tennessee
Lucid Investigative Site
Knoxville, Tennessee, United States, 37909
Lucid Investigative Site
Nashville, Tennessee, United States, 37212
United States, Texas
Lucid Investigative Site
Houston, Texas, United States, 77030
United States, Utah
Lucid Investigative Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
Lucid Investigative Site
Richmond, Virginia, United States, 23249
Lucid Investigative Site
Richmond, Virginia, United States, 23298
Lucid Investigative Site
Madrid, Spain, 28040
Lucid Investigative Site
Valladolid, Spain, 47012
Lucid Investigative Site
Zaragoza, Spain, 50009
Sponsors and Collaborators
Lucid Diagnostics, Inc.
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Study Director: Michelle McDermott Lucid Diagnostics
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Responsible Party: Lucid Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT04293458    
Other Study ID Numbers: PR-0139 / EG-CL-101
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases