Barrett Esophagus, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia, Esophageal Adenocarcinoma
Conditions
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.
Interventions
DEVICEEsoGuard
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)
Sponsors
Lucid Diagnostics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Multicenter, Single Arm
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety of EsoCheck device administration | 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 |
Countries
Spain, United States
Outcome results
None listed