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Pain, Chronic
+2

Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System

Sponsored by Nalu Medical, Inc.

About this trial

Last updated 2 years ago

Study ID

NAL-01-2020-US

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
21 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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 Neurostimulation System in adult subjects with chronic pain in the legs and back. Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation System.

What are the participation requirements?

Yes

Inclusion Criteria

1. Subject is between 21 and 80 years of age at enrollment.

2. 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.

3. Subject's pain is unresponsive to conservative treatment options.

4. Subject has a VAS Score of at least 6 in the back and/or leg at screening.

No

Exclusion Criteria

1. 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.

2. Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).

3. Subject has had an ablative procedure directed at the spinal cord including the dorsal root entry zone (DREZ) or dorsal root ganglion (DRG).

4. 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).

5. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.

Locations

Location

Status