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Monday, June 29, 2009

Pilot study shows promise for combination weight loss device

By Julie M. Donnelly

GI Dynamics has announced results from a pilot clinical study combining the company’s EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The results were presented at the 26th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS).
 
CEO Stuart Randle has said the goal is to mimic the mechanism of gastric bypass surgery, which is currently the most effective treatment for obesity, while minimizing the health risks and recovery time with a less invasive alternative.

The EndoBarrier Liner is inserted through the mouth and has a 2-foot-long impermeable membrane that lines the intestine, preventing fat from being absorbed.

The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner.
 
The small study of 10 morbidly obese people, as defined as having a body mass index between 35.8 and 47.8,  found a median weight loss of 36.7 pounds after 12 weeks. This accounted for a median weight loss of 15 percent.
 
The most common side effects included mild to moderate abdominal pain, nausea and vomiting.
 
Previous clinical trials using the EndoBarrier alone achieved half of the weight loss of the two devices used in concert, company officials said. 
 

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