LASER CATHETER FOR TREATMENT OF GASTROESOPHAGEAL REFLUX

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DESCRIPTION ( Investigator's Abstract): Gastroesophageal reflux disease (GERD) is a physical condition resulting from an inability of the lower esophageal sphincter (LES) to prevent reflux of stomach acids into the esophagus. This disease along with its associated problems is presenting in increasing numbers across the general population and current non-surgical options, in addition to being expensive, treat only the symptoms as opposed to correction of the defect. Additionally, there is increasing evidence that GERD may lead to significant increases in the risk for cancer development. The focus of this research is to develop a novel enodscopic-based laser delivery system for treatment of GERD. In this phase I study the investigators propose to develop and test a laser delivery catheter able to create a single homogeneous thermal lesion along the length of the LES. Innovative features of the catheter allow it to thermally treat the muscular layer while preventing damage to the esophageal mucosa. Studies are planned to allow optimization of the catheter's delivery parameters in vitro followed by in vivo testing in a porcine model. The investigators plan to demonstrate feasibility by assessing the system in terms of its efficacy in augmenting barrier function by improving gastric yield pressure. PROPOSED COMMERCIAL APPLICATION: It is estimated that 33% of the adult population experience heartburn at least once a month and approximately 14 million Americans, or 7% of the adult population, suffer from gastroesophageal reflux disorder (GERD). The current annual worldwide market for drugs used to treat (GERD) is approximately $14 billion. Of the 14 million GERD suffers in the U.S., only 70,000 elected for corrective invasive surgery. An effective non-surgical alternative would significantly increase the number of patients seeking permanent correction.