None listed
Conditions
Brief summary
Nalu Medical (the sponsor) is developing an implantable medical device that is designed as an adjunctive therapy to medical management of patients with chronic pain in the trunk and/or limbs. To support the design and development of this implantable device, Nalu Medical has developed an External Trial Stimulator (ETS) for use during a trial of Spinal Cord Stimulation (SCS) prior to implanting the permanent device. All commercial devices are trialed in a similar manner, through the use of a proprietary ETS, prior to permanent implant. This study is intended to evaluate the Nalu ETS.
Interventions
A commercially approved (TGA approved) spinal cord stimulator lead will be percutaneously placed in the epidural space (near the spinal cord) by a qualified physician (pain anaesthetist or neurosurgeon) as per standard implantation techniques. The choice of the commercially approved device will be up to the patient and their doctor. The procedure typically takes less than 1 hour. The leads will then be connected to the Nalu external trial stimulator (ETS) and programmed. Programming may include
A commercially approved (TGA approved) spinal cord stimulator lead will be percutaneously placed in the epidural space (near the spinal cord) by a qualified physician (pain anaesthetist or neurosurgeon) as per standard implantation techniques. The choice of the commercially approved device will be up to the patient and their doctor. The procedure typically takes less than 1 hour. The leads will then be connected to the Nalu external trial stimulator (ETS) and programmed. Programming may include a proprietary waveform intended to improve pain relief. Patients will be sent home with the NALU ETS for a maximum of 15 days. During this period the patients will return to the doctor’s office for the Nalu ETS to checked and patient assessments to be completed 3-12days after the implant. and again 3-12days later (maximum of 15 days) for the Nalu ETS trial completion after which the patient is returned to standard of care treatment . The duration of each trial period will be at the discretion of the patient and their doctor. The programming parameters used for each patient will be at the discretion of the patient and their doctor. There is no control group: all patients will receive the Nalu ETS devices. The ETS device (worn on their belt or clothing) allows the patient to turn up and down stimulation, turn on and off stimulation and to choose among pre-specified programs. Patients are expected to adhere to the study protocol and to use the devices as instructed by their doctor.
Sponsors
Nalu Medical
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Have a minimum or 1 surgical intervention of the lumbar spine 2..Have been diagnosed with chronic, intractable pain of the low back and/or legs. 3. Have been approved by their doctor to undergo a commercial trial of SCS. 4. Be an appropriate candidate for the surgical procedures required in this study. 5. Be willing and capable of giving informed consent 6. Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion criteria
1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints. 2. Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus 3. Have an active systemic or local infection 4. Be pregnant or nursing 5. Be concomitantly participating in another clinical study
Outcome results
None listed