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

Barrett Esophagus Clinical Trial

— ESOGUARDBE1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293458
• Other study ID #: PR-0139 / EG-CL-101
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: August 22, 2022

Study information

• Verified date: January 2023
• Source: PAVmed Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus Without Dysplasia
• Barretts Esophagus With Dysplasia
• Esophageal Adenocarcinoma

Intervention

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)

Locations

Country	Name	City	State
Spain	Lucid Investigative Site	Madrid
Spain	Lucid Investigative Site	Valladolid
Spain	Lucid Investigative Site	Zaragoza
United States	Lucid Investigative Site	Chapel Hill	North Carolina
United States	Lucid Investigative Site	Englewood	Colorado
United States	Lucid Investigative Site	Flowood	Mississippi
United States	Lucid Investigative Site	Greenville	South Carolina
United States	Lucid Investigative Site	Houston	Texas
United States	Lucid Investigative Site	Idaho Falls	Idaho
United States	Lucid Investigative Site	Knoxville	Tennessee
United States	Lucid Investigative Site	Macon	Georgia
United States	Lucid Investigative Site	Naples	Florida
United States	Lucid Investigative Site	Nashville	Tennessee
United States	Lucid Investigative Site	New Orleans	Louisiana
United States	Lucid Investigative Site	New York	New York
United States	Lucid Investigative Site	Oklahoma City	Oklahoma
United States	Lucid Investigative Site	Omaha	Nebraska
United States	Lucid Investigative Site	Orange	California
United States	Lucid Investigative Site	Palm Harbor	Florida
United States	Lucid Investigative Site	Philadelphia	Pennsylvania
United States	Lucid Investigative Site	Richmond	Virginia
United States	Lucid Investigative Site	Richmond	Virginia
United States	Lucid Investigative Site	Rochester	New York
United States	Lucid Investigative Site	Rockford	Illinois
United States	Lucid Investigative Site	Salt Lake City	Utah
United States	Lucid Investigative Site	Shreveport	Louisiana
United States	Lucid Investigative Site	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Lucid Diagnostics, Inc.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of EsoCheck device administration	Assessed by evaluation of AEs/SAEs/ADEs/SADEs/USADEs and Medical Device Deficiency Incidents	Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
Primary	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	Secondary Efficacy	Negative predictive value (NPV) and positive predictive value (PPV), calculated for the observed prevalence and over a range of prevalences from 1 to 15%.	Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks