The number of people who are overweight or obese has been steadily rising. In Australia, in 1980, 8.3% of the population was considered obese. By 2010, the Australian obesity rate had risen to 24.8%.~Weight loss significantly decreases early mortality as well as the development of new health-related conditions in obese subjects, and can improve many of the co-morbidities associated with obesity.~Therapies include drugs, surgery and treatment with medical devices, such as gastric banding and intragastric balloons. The TransPyloric Shuttle™ (TPS™) is a medical device that is endoscopically delivered and removed from the stomach. The TPS™ is designed to self-position across the pylorus and create an intermittent obstruction to outflow that may result in delayed gastric emptying. Slowing gastric emptying may enable an overall reduction in caloric intake by helping the subject feel full sooner (early satiation) and/or feel full longer (prolonged satiety/reduced hunger).
The purpose of this study is to assess the feasibility of the TransPyloric Shuttle™ (TPS™) when used to treat obesity.