Relievant MedSystems has completed enrolling first patient in its Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) trial for Intracept basivertebral nerve ablation procedure.
The double-blind, Level 1, prospective, randomized, sham-controlled trial is designed to assesss the efficacy of Intracept procedure in reducing pain in patients with chronic axial low back pain.
The company said the SMART trial is enrolling 200 patients.
The primary endpoint is the evaluation of patient improvement in Oswestry Disability Index (ODI) at three months compared to baseline between treatment and sham populations.
The comapany concluded that in addition, change in multiple patient-reported outcomes from baseline will be evaluated at three, six, and twelve months as well as safety evaluations at all time points.
Relievant is also commencing a separate and similar Level 1 study in Europe.