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French Endobarrier study

EndoBarrier to be assessed in two-year French study

Study will recruit 174 subjects at multiple sites throughout France

The Endobarrier will be assessed in a large, randomised, multi-centre clinical study, following approval from the French Ministry of Social Affairs and Health. The study, called ENDOMETAB, will be coordinated by the University Hospital of Lille and will be financed by the French Ministry of Social Affairs and Health over a two-year period for a total of €1.16 million.

The protocol was submitted by Professor François Pattou, professor of general surgery and head, department of general and endocrine surgery at University Hospital Lille, who also led the pilot study in Lille last year.

“Like the rest of the world, France is facing a dual crisis, 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, “said Pattou. “New approaches like EndoBarrier Therapy, which improves blood sugar and aids weight loss at the same time, represent an important advancement in the management of these diseases. We are pleased that our proposal was selected for funding and that we will be able to treat additional patients with EndoBarrier Therapy under this new protocol.”

The study will enrol 174 subjects at leading academic centres throughout France, including Lille, Toulouse, Lyon, Marseille, Montpellier, Paris and Strasbourg. The study will evaluate the impact and cost of 12 months of treatment with EndoBarrier Therapy, compared to 12 months of conventional treatment (dietary counselling, physical activity and lifestyle changes) on metabolic syndrome in patients suffering from obesity, both with and without diabetes.

“We are thrilled that the French government has recognised the benefits of EndoBarrier Therapy and agreed to fund this important new study at University Hospital of Lille following their successful completion of the EndoBarrier pilot trial in 2012,” said Stuart A Randle, president and CEO, GI Dynamics. “This study will help to clearly understand the economic impact of EndoBarrier Therapy and its role in the management of type 2 diabetes and obesity; and is a significant step toward achieving broader reimbursement in France.”

ENDOMETAB is part of the soutien aux techniques innovantes couteuses (STIC) programme, which provides government funding for innovative medical technologies that have been validated by prior clinical studies with a view toward establishing reimbursement for new devices.

 

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