This Small Business Innovation Research (SBIR) Phase I project is directed to the development of a proprietary, tissue- harvesting technology for endoscopic biopsy of the esophagus in the setting of Barrett?s Esophagus (BE). Barrett?s is a result of chronic acid reflux (?heartburn? or GERD) and is a known precursor of adenocarcinoma of the esophagus. If patients with BE are monitored and treated appropriately the chance of the development of this devastating cancer can be minimized. Monitoring is done by serial biopsies at various time intervals. These intervals are determined by the presence and type of dysplastic tissue seen with an endoscope, which is diagnosed by collecting tissue samples. The method of using biopsy forceps through an endoscope as practiced currently has a detection rate of only 30% unless a rigorous protocol is followed, however this protocol is used infrequently because of the arduous nature of that protocol. The technology being developed will improve the standard of care by providing physicians with a device that achieves the detection rate (over 70%) of the recommended protocol with an efficient, easy to use alternative, without the expense of the new high tech visualization technologies under development. The broader impact/commercial potential of this project includes the improved patient care by enhancing the detection rate of patients with this pre-cancerous condition. When a patient progresses to having adenocarcinoma, the morbidity for that condition is very high and the treatment ? surgical and chemotherapies ? are very physical debilitating and costly. The incidence of adenocarcinoma of the esophagus is increased with the presence of obesity, which has become epidemic especially in the U.S. Esophageal carcinoma has become the fastest growing cancer but the incidence can be minimized by better screening and early treatment
