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news.EnteroMedics has said that the FDA has granted approval for the expansion of its pivotal clinical trial, known as the Empower study, from 220 patients to 300 patients.
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Full enrollment is expected in the first half of 2008, consistent with previous projections, despite expansion of the study. The study currently enrolling patients at 10 of its projected 15 clinical sites, is a randomized, double-blind, placebo-controlled study being conducted to evaluate the safety and effectiveness of investigational Vbloc vagal blocking therapy using the Maestro System in obese patients.
Mark Knudson, president and CEO of EnteroMedics, said: “In obesity trials, the problem is generally not finding patients for recruitment, but supporting our clinical centers in managing the number of patients with obesity seeking help. Because of this, we are able to expand the Empower study, making its endpoint results more robust, while keeping to our original enrollment timeline.”