EndoBarrier is described as a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. It is intended for the treatment of patients who have uncontrolled type 2 diabetes and are obese.
The trial is a randomized, multi-center, double-blind, sham controlled trial that is expected to enroll approximately 500 people living with uncontrolled diabetes and obesity who meet the enrollment criteria at 25 sites in the United States.
“We are very pleased that the agency has chosen to recognize the substantial amount of scientifically sound data generated from our clinical trials conducted outside the United States, allowing us to move directly into a pivotal trial,” said Stuart A. Randle, president and CEO of GI Dynamics, in the release. “Going directly into a pivotal trial eliminates the need for a pilot trial and has the potential to accelerate commercialization of the EndoBarrier in the United States. We look forward to continuing to work with the agency to finalize the remaining details of the study and expect to initiate the trial before the end of the year.”
GI Dynamics is headquartered in Lexington, Mass.
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