French regulators will fund a trial looking at the cost and utility of the EndoBarrier device for Type II diabetes and weight loss made by GI Dynamics (ASX:GID).
The Lexington, Mass.-based medical device company’s EndoBarrier won CE Mark approval in the European Union in 2010. The new study is part of a French government program to evaluate reimbursement policies for devices already on the shelves.
The 2-year EndoMetab study is slated to enroll 174 patients and will be bankrolled by the French Ministry of Social Affairs & Health for $1.5 million.
Dr. François Pattou of the University Hospital Lille will be the principle investigator of the study, which will compare EndoBarrier to conventional weight loss treatments like diet and lifestyle counseling.
"Like the rest of the world, France is facing a dual crisis," Pattou said in prepared remarks. "Obesity and metabolic diseases are affecting more people in our nation every year; and left uncontrolled, they can lead to many other complications including kidney disease, cardiovascular disease and stroke."
Earlier this year, GI Dynamics launched a U.S. trial of the EndoBarrier device to back a pre-market approval application with the FDA. Clinical trial results released in February showed that the EndoBarrier helps control blood sugar in “mildly obese” patients with Type II diabetes.
