Clinical Trials

Inclusion Criteria: 

• Patient between the ages 18 – 90.
• Patients 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.

Exclusion Criteria: 

• Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded.
• Patients with a history of esophageal or gastric resection for esophageal or gastric 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 a 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, and Warfarin, unless discontinued for five days prior to the sponge procedure.
• Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to the sponge procedure.
• Patients on oral thrombin inhibitors including Dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure.
• Patients with a history of known varices or cirrhosis.
• Patients with a history of esophageal or gastric resection.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/22/2025. Questions regarding updates should be directed to the study team contact.