A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy

The trūFreeze™ System consists of a console containing a holding tank for medical grade liquid nitrogen and a spray tip CSATM Catheter. The physician uses the console to initiate and control the flow and duration of the cryogen spray. The liquid nitrogen is propelled through a spray CSATM Catheter to the selected site by pressure in the holding tank and freezing techniques are monitored by direct visualization with an endoscope. Once the freezing is completed, the cryogen flow is terminated and the thawing system may be engaged to allow accessory removal. If multiple cycles are used, thawing is initiated at the end of the procedure.