Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
NCT04503109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2023-02-15
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 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.
Conditions
- Pain, Chronic
- Pain, Intractable
- Pain, Back
Interventions
- DEVICE
-
Nalu Neurostimulation System
The Nalu Neurostimulation System is a Spinal Cord Stimulation system
Sponsors & Collaborators
-
Nalu Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Patrick Martin · Nalu Medical
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-16
- Primary Completion
- 2022-09-13
- Completion
- 2022-09-13
- FDA Device
- Yes
Countries
- United States
Study Locations
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