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 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/biopsies only portion of the study for RST/ARZ sites only)
* History of eosinophilic esophagitis or achalasia
* Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
* Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
* Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
* Patients with a history of known esophageal or gastric 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
* Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment
* Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer
* Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome

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

Eligibility last updated 05/20/2026. Questions regarding updates should be directed to the study team contact.