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

Sponsor
Lucid Diagnostics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04293458
Collaborator
(none)
1,000
Enrollment
30
Locations
1
Arm
34.1
Anticipated Duration (Months)
33.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: EsoGuard
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Multicenter, Single ArmMulticenter, 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 :
Feb 28, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Primary Efficacy [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
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

  1. No solid foods eaten for at least 2 hours prior to EsoCheck procedure

  2. One or more of the following risk factors:

  3. Caucasian race

  4. Current or past history of cigarette smoking

  5. BMI of at least 30 kg/m2

  6. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lucid Investigative Site Orange California United States 92868
2 Lucid Investigative Site Englewood Colorado United States 80113
3 Lucid Investigative Site Jacksonville Florida United States 32256
4 Lucid Investigative Site Naples Florida United States 34102
5 Lucid Investigative Site Palm Harbor Florida United States 34684
6 Lucid Investigative Site Macon Georgia United States 31201
7 Lucid Investigative Site Idaho Falls Idaho United States 83404
8 Lucid Investigative Site Rockford Illinois United States 61107
9 Lucid Investigative Site New Orleans Louisiana United States 70112
10 Lucid Investigative Site Shreveport Louisiana United States 71105
11 Lucid Investigative Site Wyoming Michigan United States 49519
12 Lucid Investigative Site Flowood Mississippi United States 39232
13 Lucid Investigative Site Omaha Nebraska United States 68124
14 Lucid Investigative Site New York New York United States 10016
15 Lucid Investigative Site Rochester New York United States 14620
16 Lucid Investigative Site Chapel Hill North Carolina United States 27599
17 Lucid Investigative Site Oklahoma City Oklahoma United States 73102
18 Lucid Investigative Site Philadelphia Pennsylvania United States 19107
19 Lucid Investigative Site Providence Rhode Island United States 02903
20 Lucid Investigative Site Greenville South Carolina United States 29615
21 Lucid Investigative Site Knoxville Tennessee United States 37909
22 Lucid Investigative Site Nashville Tennessee United States 37212
23 Lucid Investigative Site Houston Texas United States 77030
24 Lucid Investigative Site Salt Lake City Utah United States 84132
25 Lucid Investigative Site Richmond Virginia United States 23249
26 Lucid Investigative Site Richmond Virginia United States 23298
27 Lucid Investigative Site Bellevue Washington United States 98004
28 Lucid Investigative Site Madrid Spain 28040
29 Lucid Investigative Site Valladolid Spain 47012
30 Lucid Investigative Site Zaragoza Spain 50009

Sponsors and Collaborators

  • Lucid Diagnostics, Inc.

Investigators

  • Study Director: Randy Brown, MS, Lucid Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lucid Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT04293458
Other Study ID Numbers:
  • PR-0139 / EG-CL-101
First Posted:
Mar 3, 2020
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
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.:
Yes
Additional relevant MeSH terms:
Barrett Esophagus

Study Results

No Results Posted as of Jul 23, 2021