Clinical trial NCT04293458: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Esophageal Adenocarcinoma
Barretts Esophagus With Dysplasia
Barrett's Esophagus Without Dysplasia
Lead sponsor: PAVmed Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-03
Enrollment: 145
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, Single Arm
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Primary Efficacy
timeFrame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
Secondary outcomes:
measure: Secondary Efficacy
timeFrame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
Other outcomes:
measure: Safety of EsoCheck device administration
timeFrame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
Locations:
city: Orange
country: United States
facility: Lucid Investigative Site
state: California
city: Englewood
country: United States
facility: Lucid Investigative Site
state: Colorado
city: Naples
country: United States
facility: Lucid Investigative Site
state: Florida
city: Palm Harbor
country: United States
facility: Lucid Investigative Site
state: Florida
city: Macon
country: United States
facility: Lucid Investigative Site
state: Georgia
city: Idaho Falls
country: United States
facility: Lucid Investigative Site
state: Idaho
city: Rockford
country: United States
facility: Lucid Investigative Site
state: Illinois
city: New Orleans
country: United States
facility: Lucid Investigative Site
state: Louisiana
city: Shreveport
country: United States
facility: Lucid Investigative Site
state: Louisiana
city: Wyoming
country: United States
facility: Lucid Investigative Site
state: Michigan
city: Flowood
country: United States
facility: Lucid Investigative Site
state: Mississippi
city: Omaha
country: United States
facility: Lucid Investigative Site
state: Nebraska
city: New York
country: United States
facility: Lucid Investigative Site
state: New York
city: Rochester
country: United States
facility: Lucid Investigative Site
state: New York
city: Chapel Hill
country: United States
facility: Lucid Investigative Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Lucid Investigative Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Lucid Investigative Site
state: Pennsylvania
city: Greenville
country: United States
facility: Lucid Investigative Site
state: South Carolina
city: Knoxville
country: United States
facility: Lucid Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Lucid Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Lucid Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Lucid Investigative Site
state: Utah
city: Richmond
country: United States
facility: Lucid Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Lucid Investigative Site
state: Virginia
city: Madrid
country: Spain
facility: Lucid Investigative Site
city: Valladolid
country: Spain
facility: Lucid Investigative Site
city: Zaragoza
country: Spain
facility: Lucid Investigative Site
Study officials:
affiliation: Lucid Diagnostics
name: Michelle McDermott
role: STUDY_DIRECTOR
References: