Obesity Clinical Trial
Official title:
A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects (ENDObesity™ I Study)
The purpose of this study is to assess the feasibility of the TransPyloric Shuttle™ (TPS™) when used to treat obesity.
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).
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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