A multi-center, prospective, open label , feasibility study to evaluate Spinal Cord stimulation, in the treatment of chronic, intractable pain, using the Nalu Neurostimulation System, in adult patients.

alu Medical, Inc.0 个研究点目标入组 40 人开始时间: 2018年11月15日最近更新: 2019年11月18日

研究概览

暂无简介。

•Subjects between 21-80 years of age; subjects who have chronic (at least 6 months) intractable neuropathic pain of the leg and/or back; subject is unresponsive to conservative treatment options; subject has been diagnosed with failed back surgery syndrome; subject has a pain score of at least 6 on the baseline NRS pain diary; subject has stable pain medication use and dosage for at least 30 days prior to consent; subject has reported stable non-escalating pain for at least 30 days before consent.

•Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker; subject has previously failed SCS therapy; subject has ablative procedure directed at the spinal cord including dorsal root entry zone (DREZ); subject has mechanical spinal instability detected by > 4 mm translational movement or excessive angular movement manifested by 20 degrees greater angular movement than in an adjacent segment based on flexion/extension films of lumbar spine, subject is sensitive to skin adhesives used in the system or does not tolerate wearable aspects of the device; subject has a systemic infection; subject is unable to give informed consent; subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post menopausal); subject is nursing or breastfeeding; subject is > 120 mg-morphine equivalents per 24 hours.

发起方

alu Medical, Inc.