Medical device firm Stratus Medical has enrolled the first participant in the COBRA trial of its Nimbus radiofrequency (RF) Multitined Expandable Electrode to treat sacroiliac joint (SIJ) pain.
The randomised, double-blinded, comparative trial has been designed to compare the Nimbus bipolar RF ablation device to conventional RF ablation at three-month, six-month, 12-month, 18-month and 24-month endpoints.
It aims to quantify the effectiveness as well as the duration of relief for the popular bipolar application in the SIJ.
A total of 116 participants are expected to be enrolled and randomised at the University of Utah in the US.
The trial is backed by Stratus Medical’s investigator-initiated research grant.
Stratus Medical CEO Bret Boudousquie 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 Nimbus RF Multitined Expandable Electrode has been designed to address the unmet need for a cost-effective and easy-to-use RF ablation device.
It provides an easy-to-use and efficient solution to create a large 10mm prolate spheroid lesion for predictable and durable pain relief.
In June 2021, the company received CE Mark for its Nimbus RF device and Vesta RF Cannula.
Vesta offers high-quality and cost-effective RF cannula for clinical scenarios where the Nimbus large volume lesion is not indicated.