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Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE (ESOGUARDBE1)

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ClinicalTrials.gov Identifier: NCT04293458
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : October 5, 2020
Sponsor:
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)
Estimated Enrollment : 1000 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
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 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:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 chronic 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

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


Contacts
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Contact: Randy Brown 212-949-4319 RWB@LucidDx.com
Contact: Lisa Gott LLG@lucidDX.com

Locations
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United States, Arkansas
Lucid Investigative Site Withdrawn
Little Rock, Arkansas, United States, 72212
United States, California
Lucid Investigative Site Not yet recruiting
Orange, California, United States, 92868
United States, Colorado
Lucid Investigative Site Not yet recruiting
Englewood, Colorado, United States, 80113
United States, Florida
Lucid Investigative Site Recruiting
Jacksonville, Florida, United States, 32256
Lucid Investigative Site Recruiting
Naples, Florida, United States, 34102
Lucid Investigative Site Recruiting
Palm Harbor, Florida, United States, 34684
United States, Georgia
Lucid Investigative Site Recruiting
Macon, Georgia, United States, 31201
United States, Illinois
Lucid Investigative Site Not yet recruiting
Chicago, Illinois, United States, 60612
Lucid Investigative Site Recruiting
Rockford, Illinois, United States, 61107
United States, Louisiana
Lucid Investigative Site Recruiting
New Orleans, Louisiana, United States, 70112
United States, Michigan
Lucid Investigative Site Recruiting
Wyoming, Michigan, United States, 49519
United States, Missouri
Lucid Investigative Site Withdrawn
Kansas City, Missouri, United States, 64128
United States, New York
Lucid Investigative Site Not yet recruiting
New York, New York, United States, 10016
Lucid Investigative Site Not yet recruiting
Rochester, New York, United States, 14620
United States, North Carolina
Lucid Investigative Site Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Lucid Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Lucid Investigative Site Not yet recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Lucid Investigative Site Not yet recruiting
Greenville, South Carolina, United States, 29615
United States, Tennessee
Lucid Investigative Site Recruiting
Knoxville, Tennessee, United States, 37909
Lucid Investigative Site Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Lucid Investigative Site Not yet recruiting
Austin, Texas, United States, 78712
Lucid Investigative Site Recruiting
Houston, Texas, United States, 77030
United States, Utah
Lucid Investigative Site Recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
Lucid Investigative Site Recruiting
Richmond, Virginia, United States, 23249
Lucid Investigative Site Not yet recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Lucid Investigative Site Recruiting
Bellevue, Washington, United States, 98004
Spain
Lucid Investigative Site Not yet recruiting
Madrid, Spain, 28040
Lucid Investigative Site Not yet recruiting
Valladolid, Spain, 47012
Lucid Investigative Site Not yet recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Lucid Diagnostics, Inc.
Investigators
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Study Director: Randy Brown, MS 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: October 5, 2020
Last Verified: October 2020
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
Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases