Clinical Trials

Inclusion Criteria:

• Subjects with known Barrett's Esophagus (BE):
  • Between the ages 18 - 90 years old;
  • With a BE segment ≥ 1cm in maximal extent endoscopically;
  • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia;
  • Undergoing clinically indicated endoscopy.
• Subjects without known evidence of BE:
  • Undergoing clinically indicated diagnostic endoscopy.

Exclusion Criteria:

• Subjects with known Barrett's Esophagus (BE):
  • Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded;
  • Patients with history of esophageal resectiobn for esophageal carcinoma.
• Subjects with or without known evidence of BE (on history or review of medical records):
  • Pregnant or lactating females;
  • Patients who are unable to consent;
  • Patients with current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study);
  • History of eosinophilic esophagitis, achalasia;
  • Patients on oral anticoagulation including Coumadin, Warfarin;
  • Patients on antiplatelet agents including Clopidogrel, unless discontinued for at least three days prior to the sponge procedure;
  • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for at least three days prior to the sponge procedure;
  • Patients with history of known varices or cirrhosis;
  • Patients with history of esophageal resection for esophageal carcinoma;
  • Patients with congenital or acquired bleeding diatheses;
  • Patients with a history of esophageal squamous dysplasia;
  • Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.