Stratus® Medical announces first patient enrolled in important double-blinded, randomized, comparative trial comparing the Nimbus® radiofrequency ablation device to conventional radiofrequency ablation for the treatment of Sacroiliac Joint pain
MAGNOLIA, Texas, March 9, 2023 /OrthoSpineNews/ — Stratus® Medical, a company focused on advancing radiofrequency (RF) ablation treatment for pain, and the University of Utah, Department of Physical Medicine and Rehabilitation, announced today the first patient enrolled in the COBRA study, a double-blinded, randomized trial, comparing the bipolar treatment with Nimbus® RF Multitined Expandable Electrode to conventional radiofrequency ablation for the treatment of sacroiliac joint (SIJ) pain.
Study to Measure Radiofrequency Ablation Outcomes for Sacroiliac Joint Pain with Nimbus
This IRB-approved study will be the first level I, double-blinded, randomized control trial to compare Nimbus bipolar radiofrequency ablation to conventional radiofrequency ablation at three-month, six-month, 12 month, 18 month, and 24 month endpoints. The goal of the study is to quantify effectiveness and duration of relief for the popular bipolar application in the sacroiliac joint. This study contemplates the enrollment and randomization of 116 patients at the University of Utah, and is supported by an investigator-initiated research grant from Stratus Medical. For more information visit: https://www.clinicaltrials.gov/ct2/show/NCT05409443
Principle investigator, Dr. Aaron Conger, Assistant Professor and Interventional Spine and Musculoskeletal Medicine Physician at the University of Utah in the Department of Physical Medicine and Rehabilitation (PM&R), commented “This study will be one of the largest and best designed SIJ RFA trials performed to date. We expect the results will significantly impact practice patterns regarding electrode choice for many physicians who treat SIJ pain and will further bolster the existing evidence for SIJ radiofrequency ablation. We thank Stratus Medical for their partnership in funding this important research.”
Dr. Zachary McCormick, Associate Professor and Division Chief of Spine and Musculoskeletal Medicine at the University of Utah in the Department of PM&R, said “The treatment of chronic, refractory sacroiliac joint pain remains a challenging problem. We are pleased to be able to contribute to the clinical science through this pragmatic randomized trial.”
Bret Boudousquie, Stratus Medical CEO, offered “We are delighted to support this important investigator-initiated research comparing our highly differentiated and patented Nimbus RF technology to conventional RF needles for the treatment of sacroiliac joint pain. Nimbus is rapidly becoming the preferred large volume lesion nerve ablation technology to treat pain due to reproducible and sustained pain relief, faster procedure times and lower procedure cost. We expect this research will further validate the significant clinical advantages of Nimbus compared to conventional RF needles.”
About Stratus Medical – Stratus Medical is a medical device company focused on improving clinical outcomes for chronic pain patients by advancing RF technology for the treatment of pain. The Nimbus® RF Multitined Expandable Electrode addresses the unmet need for an easy-to-use and cost-effective radiofrequency ablation device that provides a large volume lesion for predictable and durable pain relief. Stratus Medical is headquartered in Magnolia, Texas.
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Cody Jorgensen
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Stratus Medical
346-703-0642
cody@stratusmedical.com
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SOURCE Stratus Medical
