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

• ClinicalTrials.gov Identifier: NCT04293458
• Recruitment Status: Completed
• First Posted: March 3, 2020
• Last Update Posted: January 25, 2023
• Sponsor: Lucid Diagnostics, Inc.
• Information provided by (Responsible Party): PAVmed Inc. ( Lucid Diagnostics, Inc. )

Tracking Information

• First Submitted Date: February 26, 2020
• First Posted Date: March 3, 2020
• Last Update Posted Date: January 25, 2023
• Actual Study Start Date: February 28, 2020
• Actual Primary Completion Date: August 22, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 29, 2020)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 29, 2020)

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%.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 29, 2020)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
• 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Multicenter, Single Arm

Masking: None (Open Label)
Primary Purpose: Screening

Condition

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

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)

Study Arms

Experimental: EsoCheck vs. EGD with or without biopsies

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

Intervention: Device: EsoGuard

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 30, 2022): 145
• Original Estimated Enrollment (submitted: February 29, 2020): 1000
• Actual Study Completion Date: August 22, 2022
• Actual Primary Completion Date: August 22, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain, United States

Administrative Information

• NCT Number: NCT04293458
• Other Study ID Numbers: PR-0139 / EG-CL-101
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: PAVmed Inc. ( Lucid Diagnostics, Inc. )
• Original Responsible Party: Same as current
• Current Study Sponsor: Lucid Diagnostics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Michelle McDermott; Lucid Diagnostics

• PRS Account: PAVmed Inc.
• Verification Date: January 2023