NCT04293458

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
2 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2.5 years

First QC Date

February 26, 2020

Last Update Submit

January 23, 2023

Conditions

Barrett EsophagusEsophageal AdenocarcinomaBarretts Esophagus With DysplasiaBarrett's Esophagus Without Dysplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Secondary Efficacy

    Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks

Other Outcomes (1)

  • Safety of EsoCheck device administration

    Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks

Study Arms (1)

EsoCheck vs. EGD with or without biopsies

EXPERIMENTAL

All subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies)

Device: EsoGuard

Interventions

EsoGuardDEVICE

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)

EsoCheck vs. EGD with or without biopsies

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men aged 50 years old and older
  • ≥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
  • No solid foods eaten for at least 2 hours prior to EsoCheck procedure
  • One or more of the following risk factors:
  • Caucasian race
  • Current or past history of cigarette smoking
  • BMI of at least 30 kg/m2
  • First-degree relative with BE or EAC

You may not qualify if:

  • History of prior EGD procedure
  • Inability to provide written informed consent
  • On anti-coagulant drug(s) that cannot be temporarily discontinued
  • Known history of esophageal varices or esophageal stricture
  • 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
  • History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  • Oropharyngeal tumor
  • History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
  • History of myocardial infarction or cerebrovascular accident within past 6 months
  • History of esophageal motility disorder
  • Currently implanted Linx device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Lucid Investigative Site

Orange, California, 92868, United States

Location

Lucid Investigative Site

Englewood, Colorado, 80113, United States

Location

Lucid Investigative Site

Naples, Florida, 34102, United States

Location

Lucid Investigative Site

Palm Harbor, Florida, 34684, United States

Location

Lucid Investigative Site

Macon, Georgia, 31201, United States

Location

Lucid Investigative Site

Idaho Falls, Idaho, 83404, United States

Location

Lucid Investigative Site

Rockford, Illinois, 61107, United States

Location

Lucid Investigative Site

New Orleans, Louisiana, 70112, United States

Location

Lucid Investigative Site

Shreveport, Louisiana, 71105, United States

Location

Lucid Investigative Site

Wyoming, Michigan, 49519, United States

Location

Lucid Investigative Site

Flowood, Mississippi, 39232, United States

Location

Lucid Investigative Site

Omaha, Nebraska, 68124, United States

Location

Lucid Investigative Site

New York, New York, 10016, United States

Location

Lucid Investigative Site

Rochester, New York, 14620, United States

Location

Lucid Investigative Site

Chapel Hill, North Carolina, 27599, United States

Location

Lucid Investigative Site

Oklahoma City, Oklahoma, 73102, United States

Location

Lucid Investigative Site

Philadelphia, Pennsylvania, 19107, United States

Location

Lucid Investigative Site

Greenville, South Carolina, 29615, United States

Location

Lucid Investigative Site

Knoxville, Tennessee, 37909, United States

Location

Lucid Investigative Site

Nashville, Tennessee, 37212, United States

Location

Lucid Investigative Site

Houston, Texas, 77030, United States

Location

Lucid Investigative Site

Salt Lake City, Utah, 84132, United States

Location

Lucid Investigative Site

Richmond, Virginia, 23249, United States

Location

Lucid Investigative Site

Richmond, Virginia, 23298, United States

Location

Lucid Investigative Site

Madrid, 28040, Spain

Location

Lucid Investigative Site

Valladolid, 47012, Spain

Location

Lucid Investigative Site

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Barrett EsophagusAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Michelle McDermott

    Lucid Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Multicenter, Single Arm
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 3, 2020

Study Start

February 28, 2020

Primary Completion

August 22, 2022

Study Completion

August 22, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)US(24)