Degenerative Disc Disease Clinical Trial
Official title:
A Prospective Study to Assess the Safety and Performance of the Discure Technologies System for the Treatment of Early to Moderate Degenerative Disc Disease (DDD).
The objective of this study is to evaluate the safety and performance of the Discure System therapy in subjects with early to moderate degeneration of the disc (DDD).
A prospective, interventional, multi-center, single arm, open label, feasibility study. The study is designed to evaluate the safety and performance of the Discure System in the treatment of chronic low back pain (with or without radicular pain) of discogenic origin with early to moderate degeneration of the disc (DDD) in levels L1-2 to L5-S1, as confirmed by history and radiographic studies and/or discography, who failed conservative treatment of 12 weeks in duration. Subjects will be followed at 1,3-, and 6-months post procedure. The primary endpoint will be assessed at the 6-month follow-up visit. The study will enroll up to 20 subjects at up to 8 sites. ;
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