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

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

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.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma; Barrett's Esophagus Without Dysplasia; Barretts Esophagus With Dysplasia
• Intervention / Treatment: Device: EsoGuard

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.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Lucid Investigative Site
  • Valladolid, Spain, 47012
    • Lucid Investigative Site
  • Zaragoza, Spain, 50009
    • Lucid Investigative Site
• United States
  • California
    • Orange, California, United States, 92868
      • Lucid Investigative Site
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Lucid Investigative Site
  • Florida
    • Naples, Florida, United States, 34102
      • Lucid Investigative Site
    • Palm Harbor, Florida, United States, 34684
      • Lucid Investigative Site
  • Georgia
    • Macon, Georgia, United States, 31201
      • Lucid Investigative Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Lucid Investigative Site
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Lucid Investigative Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Lucid Investigative Site
    • Shreveport, Louisiana, United States, 71105
      • Lucid Investigative Site
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Lucid Investigative Site
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Lucid Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Lucid Investigative Site
  • New York
    • New York, New York, United States, 10016
      • Lucid Investigative Site
    • Rochester, New York, United States, 14620
      • Lucid Investigative Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lucid Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Lucid Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Lucid Investigative Site
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Lucid Investigative Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Lucid Investigative Site
    • Nashville, Tennessee, United States, 37212
      • Lucid Investigative Site
  • Texas
    • Houston, Texas, United States, 77030
      • Lucid Investigative Site
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Lucid Investigative Site
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Lucid Investigative Site
    • Richmond, Virginia, United States, 23298
      • Lucid Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy	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.	Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lucid Diagnostics, Inc.
• Investigators: Study Director: Michelle McDermott, Lucid Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 29, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: PR-0139 / EG-CL-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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