Sam Brusco, Associate Editor03.03.23
Stratus Medical, a company aiming to advance radiofrequency (RF) ablation to treat pain, has enrolled the first patient in its COBRA study at the University of Utah Department of Physical Medicine and Rehabilitation.
The double-blinded, randomized trial will compare bipolar treatment with the Nimbus RF multitined expandable electrode to conventional RF ablation to treat sacroiliac (SI) joint pain.
The two methods will be compared at three-month, six-month, 12-month, 18-month, and 24-month endpoints. The study aims to quantify effectiveness and duration of relief for the bipolar application in the SI joint. The COBRA trial hopes to enroll and randomize 116 patients at the University of Utah.
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), told the press, "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, added, "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, said, "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."
The double-blinded, randomized trial will compare bipolar treatment with the Nimbus RF multitined expandable electrode to conventional RF ablation to treat sacroiliac (SI) joint pain.
The two methods will be compared at three-month, six-month, 12-month, 18-month, and 24-month endpoints. The study aims to quantify effectiveness and duration of relief for the bipolar application in the SI joint. The COBRA trial hopes to enroll and randomize 116 patients at the University of Utah.
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), told the press, "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, added, "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, said, "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."