The Empower study is a randomized, double-blind, placebo-controlled study and will include up to 220 patients across 15 clinical sites in the US and Australia. The company expects to complete enrollment during the first half of 2008.
The VBLOC Therapy system is said to be the only neuroblocking device currently under investigation for the potential treatment of obesity. Upon completion of the first year of the trial, EnteroMedics plans to use data from this study to support a premarket approval, or PMA, application to the FDA for the treatment of obesity in the US.
Mark Knudson, president and CEO of EnteroMedics, said: “The Empower trial, whose objective is to evaluate a new and potentially effective, lower risk option for the treatment of obesity, is being conducted in partnership with several nationally and internationally recognized obesity experts and institutions.”