Background: The TransPyloric Shuttle™ (TPS) is a nonsurgical device that is endoscopically delivered to and removed from the stomach to treat obesity. The device consists of a large spherical bulb connected to a smaller cylindrical bulb by a flexible tether. The larger bulb prevents migration from the stomach, while the smaller bulb passes freely into the duodenum to position the TPS across the pylorus. Transpyloric positioning may delay gastric emptying, reducing caloric intake and enabling weight loss. The purpose of this feasibility study was to evaluate the safety and efficacy of the clinical procedure and device.
Methods: Twenty patients with a mean body mass index (BMI) of 36.0 kg/m(2) were assigned to 2 groups of 10 patients scheduled to have the device for 3 or 6 months. Primary outcomes included % excess weight loss (%EWL), % excess BMI loss (%EBMIL), % weight loss (%WL), and adverse events.
Results: Devices were deployed and retrieved in all patients with no complications. Three-month patients had mean %EWL of 25.1%, mean %EBMIL of 33.1%, and mean %WL of 8.9%. Six-month patients had mean %EWL of 41.0%, mean %EBMIL of 50.0%, and mean %WL of 14.5%. Early device removal occurred in 2 patients due to symptomatic gastric ulcerations, which resolved after device removal.
Conclusions: The TPS is a promising technology that provides a, nonsurgical, ambulatory method for weight loss.
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