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

Lucid Diagnostics

Status: Completed

Conditions: Barretts Esophagus With Dysplasia; Barrett's Esophagus Without Dysplasia; Barrett Esophagus; Esophageal Adenocarcinoma

Treatments: Device: EsoGuard

Study type: Interventional

Funder types: Industry

Identifiers

NCT04293458

PR-0139 / EG-CL-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

EsoCheck vs. EGD with or without biopsies

Experimental group

Description:

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

Treatment:

Device: EsoGuard