A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects
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|ClinicalTrials.gov Identifier: NCT01386905|
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : March 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: BAROnova™ TransPyloric Shuttle™ (TPS™)||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects (ENDObesity™ I Study)|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||May 2012|
Device: BAROnova™ TransPyloric Shuttle™ (TPS™)
- ENDObesity I Study™
- TransPyloric Shuttle™
- Feasibility of the TransPyloric Shuttle™ System (TPS™) [ Time Frame: Up to 6 months post-placement ]Preliminary evidence of the effectiveness of the TPS™ as determined by percent weight loss, excess BMI loss, and excess weight loss.
- Effect of the TransPyloric Shuttle™ (TPS™) on Patient Quality of Life [ Time Frame: Up to 6 months post-placement ]Preliminary evidence of the effect of TPS™ on patient quality of life measured by lifestyle questionnaire 'Impact of Weight on Quality of Life-Lite' (IWQOL-Lite).
- Safety of the TransPyloric Shuttle™ (TPS™) [ Time Frame: Up to 6 months post-placement ]Preliminary evidence of TPS™ safety measured by device-related and procedure-related adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386905
|Australia, New South Wales|
|Gastric Balloon Australia (GBA)|
|Bondi Junction, New South Wales, Australia, 2022|
|Principal Investigator:||George Marinos, MD||Gastric Balloon Australia|