US-based Nalu Medical has enrolled the first patient in its COMFORT-2 peripheral nerve stimulation (PNS) randomised controlled study for a micro-implantable pulse generator.
The trial will assess the safety and efficacy of the pulse generator to treat peripheral neuropathic pain.
The first patient has been enrolled by Dr John Hathewayat, an interventional pain physician at Northwest Pain Care in Spokane, Washington.
COMFORT-2, along with COMFORT-1, intends to recruit the largest cohort of randomised controlled trial patients and this latest study will recruit a maximum of 200 patients across 20 centres in the US.
Participants with mononeuropathy, neuropathic pain, peripheral neuralgia or osteoarthritis pain in the lower back, knee, shoulder or foot will be randomised in the study.
They will receive a combination of PNS and conventional treatments or conventional treatments alone.
The responder rate and the rate of serious and non-serious adverse events at three months are the primary endpoints of the trial.
Furthermore, the patient-reported functional outcomes, as well as responder rates and the rate of serious and non-serious adverse events at six and 12 months, are the secondary endpoints.
Nalu Medical CEO and president Tom West said: “This milestone marks an important step in clinically validating the efficacy of the Nalu PNS system for the long-term treatment of chronic intractable peripheral neuralgia of post-traumatic or post-surgical origin.”
The Nalu neurostimulation system for PNS received approval from the US Food and Drug Administration to treat severe intractable chronic pain of peripheral nerve origin in adults.
It can be used either as the sole mitigating agent or as an adjunct to other modes of therapy.
The Nalu PNS system integrates a micro implantable pulse generator (micro-IPG) that operates without a battery.
The system is driven by an externally worn device (Therapy Disc), which contains both the battery and controller.
It uses gentle electrical impulses to create an energy field that interrupts pain signals before they reach the brain.
