MAGNOLIA, Texas, May 18, 2021 /PRNewswire/ — Stratus™ Medical, a company focused on advancing radiofrequency (RF) ablation treatment for chronic pain, and KU Medical Center, Interventional Pain Medicine Department, announced today the first patient enrolled in the EMERALD study, a level I, prospective, randomized control trial, comparing the Nimbus® RF Multitined Expandable Electrode to conservative care.
Study to Measure Radiofrequency Ablation for Pain Efficacy with Nimbus
This IRB-approved study will be the first level I, prospective, randomized control trial to compare Nimbus radiofrequency ablation to conservative care at one-month, three-month, six-month, nine-month and twelve-month endpoints. The goal of the study is 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. This single-site study plans to enroll and randomize 100 patients for this endeavor. This study is supported by an educational grant from Stratus Medical. For more information visit: https://clinicaltrials.gov/ct2/show/NCT04730700
Dr. Dawood Sayed, Chief of Pain Medicine at the University of Kansas Medical Center and Principal Investigator, commented “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.”
Dr. Christopher Lam, Co-Investigator at the University of Kansas Medical Center, added “With the pace that pain medicine is advancing, adding evidence behind our practice is paramount. Evaluating one of the most common procedures in our armamentarium will be a positive step for the clinical literature in our field.”
Bret Boudousquie, Stratus Medical CEO, offered “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.”
About Stratus Medical – Stratus Medical is a medical device company focused on reducing pain and suffering and improving the quality of life for chronic pain patients through innovation. The Nimbus® RF Multitined Expandable Electrode addresses the unmet need for an easy-to-use and cost-effective radiofrequency ablation device which provides a large volume lesion for sustained pain relief. Stratus Medical is headquartered in Magnolia, Texas.
SOURCE Stratus Medical