A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects
The purpose of this study is to assess the safety and effectiveness of the TransPyloric Shuttle™ (TPS™) when used to treat obesity.
The Null Hypothesis is that the mean percent Excess Weight Loss (EWL) at 12 weeks will be equal to the mean percent EWL at 12 weeks for historical controls; whereas, the Alternative Hypothesis is that the two means are not equal.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects (ENDObesity™ I Study)|
- Safety of the TransPyloric Shuttle™ System (TPSS) [ Time Frame: Up to 6 months post-placement ] [ Designated as safety issue: Yes ]Safety of the TPSS in obese subjects as evidenced by the rate of adverse device effects.
- Effectiveness of the TransPyloric Shuttle™ (TPS™) [ Time Frame: Up to 6 months post-placement ] [ Designated as safety issue: No ]Preliminary evidence of the effectiveness of the TPS™ as determined by the percent of excess weight loss (%EWL) and reduction in body circumference measurements.
|Study Start Date:||June 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Device: BAROnova™ TransPyloric Shuttle™ (TPS™)
- ENDObesity I Study™
- TransPyloric Shuttle™
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).
|Australia, New South Wales|
|Gastric Balloon Australia (GBA)|
|Bondi Junction, New South Wales, Australia, 2022|
|Principal Investigator:||George Marinos, MD||Gastric Balloon Australia|