Abstract
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/m2 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.
Keywords
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Article info
Publication history
Published online: March 13, 2014
Accepted:
March 2,
2014
Received:
October 15,
2013
Footnotes
☆This study was funded by BAROnova, Inc., 281 Magnolia Ave, Goleta, CA 93117, USA.
Identification
Copyright
© 2014 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
