Status:
COMPLETED
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
Lead Sponsor:
Nalu Medical, Inc.
Conditions:
Pain, Chronic
Pain, Intractable
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety, comfort and compliance with the Nalu Neurostim...
Detailed Description
The study is a prospective, multi-center, open-label, single-arm clinical study with each subject serving as their own control. The study will confirm device efficacy, safety, comfort and compliance w...
Eligibility Criteria
Inclusion
- Subject is between 21 and 80 years of age at enrollment.
- Subject has chronic (defined as at least 6 months duration), intractable neuropathic pain of legs and/or back; any nociceptive pain must be less prominent than the neuropathic pain.
- Subject's pain is unresponsive to conservative treatment options.
- Subject has a VAS Score of at least 6 in the back and/or leg at screening.
Exclusion
- 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 (either trial system evaluation or permanent implant).
- Subject has had an ablative procedure directed at the spinal cord including the dorsal root entry zone (DREZ) or dorsal root ganglion (DRG).
- Subject has pain in another anatomic region besides the leg(s) and back that would interfere with their ability to accurately report pain (e.g. hip joint pain).
- Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04503109
Start Date
July 16 2020
End Date
September 13 2022
Last Update
February 15 2023
Active Locations (8)
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1
CA Ortho and Spine
Larkspur, California, United States, 94939
2
IPM Medical Group, Inc.
Walnut Creek, California, United States, 94598
3
International Spine, Pain and Performance Center
Washington D.C., District of Columbia, United States, 20006
4
The Orthopaedic Institute
Gainesville, Florida, United States, 32607