Neuros Medical—a medical device company developing novel high-frequency nerve block technology for patients with intractable post-amputation pain—has announced the completion of enrolment in its pivotal QUEST (High-frequency nerve block for post-amputation pain) study.
QUEST is a 180-subject, randomised, double-blinded, active sham-controlled clinical trial that is being conducted under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). It is designed to assess the safety and effectiveness of the company’s Altius high-frequency nerve block system to treat intractable post-amputation pain.
Post-amputation pain is a significant unmet medical need, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids, according to a Neuros press release.
“I wish to thank the QUEST investigators and their clinical research teams for their remarkable work on this study, including challenges in navigating the recent resurgence of COVID-19 cases this summer,” said Leonardo Kapural (Carolinas Pain Institute, Winston-Salem, USA), national principal investigator of the QUEST study. “I am hopeful that a successful trial result will enable the Altius therapy, with its unique mechanism of action achieved through high-frequency nerve block, to become an important treatment option for post-amputation phantom and stump pain.”
“We join Dr Kapural in recognising the QUEST site clinical research teams for their continued commitment and dedication to the study, as well as to the amputee subjects they enrolled,” said Neuros CEO David Veino. “I also wish to thank our entire Neuros team for a tremendous effort, particularly during the past 18 months. This is a key milestone in our efforts to develop a promising treatment option for this significant unmet medical need.”