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Completed

NCT Number: NCT04293458

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

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.

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Key information

Conditions

Barrett Esophagus Adenocarcinoma Of Esophagus Barrett's Esophagus Without Dysplasia Barretts Esophagus With Dysplasia Digestive System Diseases Esophageal Adenocarcinoma Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lucid Investigative Site, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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Exclusion criteria

  • 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

Treatment and study plan

EsoGuard

Device

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lucid Diagnostics, Inc.

Industry

Registry information

Official study 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

Acronym: ESOGUARDBE1

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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