The SMART trial (Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) is a prospective, randomized, double-blind, sham-controlled investigation evaluating the reduction of pain in patients with chronic axial low back pain. The pivotal study will treat 200 patients at major medical centers around the United States with the Intracept System to determine the safety and effectiveness of this product. Enrollment in the SMART trial will begin this summer, with data analysis after the last subject has completed six months of follow-up.
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