Principal Investigator: John Fang
Keywords: EsoGuard , EGD , Barrett's Esophagus , Esophagogastroduodenoscopy Alternative Department: Gastroenterology
IRB Number: 00130827
Specialty: Gastroenterology, Gastroenterology, Gastroenterology, Gastroenterology
Sub Specialties: Esophageal Diseases, Barrett's Esophagus, Endoscopy
Recruitment Status: Recruiting

Contact Information

Brinnlie Harward

Brief Summary

The primary objective of this study is to determine the operating characteristics (sensitivity, specificity, positive predictive value and negative predictive value) of the EsoGuard diagnostic assay for the detection of BE on samples collected using EsoCheck, using EGD findings plus histopathologic examination of biopsies as the reference method, in a population for whom a screening procedure is indicated per the guidance of the ACG.

Inclusion Criteria

1. Men aged 50 years and above

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:

  • Caucasian race

  • Current or past history of cigarette smoking

  • Body mass index (BMI) of at least 30 kg/m2

  • 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, whether physician diagnosed or partient reported, of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills or sensation of food being stuck in the throat or esophagus, and/or significant anxiety from, or difficulty tolerating dental procedures due to gagging

  7. Oropharyngeal tumor

  8. History of esophageal or gastric surgery, with exception on 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