Clinical Trials

Inclusion Criteria:

• All participants will be 50 years of age or older and younger than 85 years of age. 
• All participants will be stratified into those with or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week, or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis).
• Other risk factors considered would include:
  • Caucasian race;
  • History of ever smoking (current or prior history of smoking);
  • BMI greater than equal to 30;
  •  Family history of Barrett's esophagus or esophageal adenocarcinoma;
  •  Male sex.

Exclusion Criteria:

• History of Barrett's esophagus or esophageal adenocarcinoma.
• Prior endoscopy in the last 10 years.
• Pregnant or lactating females.
• Patients who are unable to consent.
• Patients with current history of uninvestigated dysphagia
• History of eosinophilic esophagitis, achalasia.
• Patients on oral anticoagulation including Coumadin, Warfarin.
• Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
• Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
• Patients with history of known varices or cirrhosis.
• Patients with history of esophageal or gastric resection.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
• Identification of patients meeting inclusion and exclusion criteria was done using two institutional EMR search tools (i2b2 and ACE) using ICD and CPT codes listed below along with NLP for some terms.