Stratus Medical and the University of Kansas Medical Center have announced that the first patient has been enrolled in the EMERALD study–a level I, prospective, randomised control trial, comparing the Nimbus radiofrequency (RF) multitined expandable electrode to conservative care for those with chronic lower back pain.
The study aims to quantify efficacy and duration of relief for the most common application of radiofrequency ablation for pain, medial branch ablation for facet mediated back pain at at one-month, three-month, six-month, nine-month and twelve-month endpoints. This single-site study, which is supported by an educational grant from Stratus Medical, plans to enroll and randomise 100 patients for this endeavour.
Dawood Sayed, chief of pain medicine at the University of Kansas Medical Center and principal investigator of the study, said: “Radiofrequency ablation for chronic low back pain is one of the most common procedures we do as interventional pain medicine physicians, and there is limited clinical evidence demonstrating predictable and durable pain relief for RF for pain.
“Our hypothesis is that, due to the unique design of Nimbus and the large volume lesion that it provides, Nimbus outcomes will be predictable in the lumbar spine, the most common application of RF for pain.”
Bret Boudousquie, Stratus Medical CEO, added: “It is very important we support world class clinical research on radiofrequency ablation for pain with our highly differentiated and patented Nimbus technology. We are proud to work with the excellent physicians at the KU Medical Center to expand the body of evidence for this important interventional therapy for chronic pain patients.”