RADIOFREQUENCY ABLATION OF BARRETT'S ESOPHAGUS

DESCRIPTION (provided by applicant): The overall goal of this research program is to optimize and validate a novel endoscopic device to ablate high-grade dysplasia resulting from Barrett's esophagus, thereby preventing it from progressing to esophageal cancer. The Stellartech Coagulation System is a novel and proprietary device for ablating premalignant esophageal cells by delivering radio-frequency energy through a balloon catheter carrying an external electrode array. Energy delivery is exquisitely controlled so that it kills only the dysplastic outer layer of cells without damaging the underlying muscle layer. Preliminary studies with a prototype device have demonstrated its safety and efficacy in a porcine model. In Phase I of this Fast-Track SBIR-at-NIDDK project, we propose to: 1) design and test new geometric arrangements of the electrode array; 2) optimize treatment parameters to maximize the efficiency of ablation in a single treatment session; 3) conduct a preclinical safety study in pigs to demonstrate that the device is safe for testing in patients with Barrett's esophagus; and 4) evaluate real-time feedback systems to monitor treatment as an optional improvement to the device. Successful completion of these milestones will lead to the SBIR Phase II project to integrate the balloon catheter into a standard clinical endoscope and test its efficacy in a multi-center clinical trial of patients with high-grade Barrett's esophagus.