Seeking Men, Age 50 and Over,
With Heartburn symptoms for at least 5 years
- Are you Male and at least 50 years of age?
- Have you had recurrence of heartburn symptoms for at least 5 years?
- If you have never had an upper endoscopy to evaluate your symptoms, and are planning to schedule your first one?
If so, you may be eligible to participate in the Lucid EsoCheck study. All subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies).
The EsoCheck a device that collects cells from the esophagus in a five-minute procedure, without the need for endoscopy, for the diagnosis of Barrett’s Esophagitis and related conditions.
Required Inclusion Criteria
- Men aged 50 years old and older
- 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
- No solid foods eaten for at least 2 hours prior to EsoCheck procedure
- One or more of the following risk factors:
a. Caucasian race
b. Current or past history of cigarette smoking
c. BMI of at least 30 kg/m2
d. First-degree relative with Barrett’s Esophagitis or Esophageal Cancer
Exclusion Criteria that will prohibit candidates from entering trial:
- History of prior EGD procedure
- Inability to provide written informed consent
- On anti-coagulant drug(s) that cannot be temporarily discontinued
- Known history of esophageal varices or esophageal stricture
- 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
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
- History of myocardial infarction or cerebrovascular accident within past 6 months
- History of esophageal motility disorder
- Currently implanted Linx device
If you qualify you will receive the Lucid EsoCheck procedure, and compensation for your time and travel.
It is important to know that the trial does not cover the costs of the Endoscopy, which will need to be performed by one of our physicians and will be the responsibility of the patient or their insurance company.
The following link will show you the process of this simplistic, non-evasive procedure: https://www.youtube.com/watch?v=iiv0Gws4sdA
This trial can be further reviewed on www.clinicaltrials.gov under the following link: https://clinicaltrials.gov/ct2/show/NCT04293458
Other important readings: https://www.globenewswire.com/news-release/2020/04/02/2010842/0/en/PAVmed-Subsidiary-Lucid-Diagnostics-EsoCheck-Esophageal-Cell-Collection-Device-Receives-Prestigious-Edison-Best-New-Product-Award.html