Stratus Medical has announced the first patient enrolled in the COBRA study, a double-blinded, randomised trial, comparing the bipolar treatment with Nimbus RF multitined expandable electrode to conventional radiofrequency ablation for the treatment of sacroiliac joint (SIJ) pain.
This institutional review board (IRB)-approved study will be the first level I, double-blinded, randomised 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, according to a recent press release.
The goal of the study, say Stratus Medical, is to quantify effectiveness and duration of relief for the popular bipolar application in the sacroiliac joint. This study contemplates the enrolment and randomisation of 116 patients at the University of Utah, and is supported by an investigator-initiated research grant from the company.
Principle investigator, Aaron Conger, assistant professor and interventional spine and musculoskeletal medicine physician at the University of Utah (Salt Lake City, USA), said: “This study will be one of the largest and best designed SIJ radiofrequency ablation 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.”
Zachary McCormick, associate professor and division chief of spine and musculoskeletal medicine at the University of Utah, 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 randomised trial.”
Bret Boudousquie, Stratus Medical CEO, commented: “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.”