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

Not Applicable

Completed

• Conditions: Barrett Esophagus; Barretts Esophagus With Dysplasia; Barrett's Esophagus Without Dysplasia; Esophageal Adenocarcinoma
• Interventions: Device: EsoGuard

• Registration Number: NCT04293458
• Lead Sponsor: Lucid Diagnostics, Inc.

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.

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 Timeline

• Study First Submitted: 2020-02-26
• Study Start: 2020-02-28
• Study First Submitted QC: 2020-02-29
• Study First Posted: 2020-03-03
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-22
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 145

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EsoCheck vs. EGD with or without biopsies	EsoGuard	All subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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%.

Trial Locations

Locations (1)

Lucid Investigative Site; 🇪🇸 Zaragoza, Spain