This research study is looking at a newer treatment option for Barrett's Esophagus (BE) which uses Nitrous Oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA cleared device, is another, newer way of treating Barrett's Esophagus. To evaluate the newer treatment, we are enrolling patients who are not responding as well as expected to RFA. Patients with at least 2 or more previous RFA treatments who still have BE may be eligible.
You will receive cryotherapy about every 2-3 months for up to one year (12 months). - Prior to each cryotherapy visit, you will meet with a member of the study team and complete questionnaires. - After each cryotherapy visit, you will complete a questionnaire at home and receive phone calls 1, 7, and 30 days to check on your health. After completing cryotherapy, the study team will follow you up to one year (12 months) to collect information about your health. Your doctor will ask you to come in at least once every 6 months, but may ask you to come back more often to check on your health. Throughout the research study, all treatments and procedures will be a part of your normal clinical care and the study team will collect information about your health from your medical record.
GI Clinic
NC Memorial Hospital
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Nicholas Shaheen
Center for Gastrointestinal Biology and Disease
Clinical or Medical
Observational
Stomach, Digestion and Gut Health
18-0388