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Home » Diabetes/Obesity Device to Skip Pilot, Go Straight to Pivotal Trial
Diabetes/Obesity Device to Skip Pilot, Go Straight to Pivotal Trial
September 12, 2012
The FDA has given GI Dynamics a conditional go-ahead to launch a pivotal clinical trial of its EndoBarrier for obese patients with Type 2 diabetes without first conducting a pilot study, a tribute to the caliber of research sites used in earlier studies conducted outside the U.S., the devicemaker says.