NCT04503109

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

August 3, 2020

Last Update Submit

February 13, 2023

Conditions

Pain, ChronicPain, IntractablePain, Back

Keywords

Spinal Cord StimulationChronic Leg and Back PainFailed Back Surgery Syndrome (FBSS)

Outcome Measures

Primary Outcomes (1)

  • Responders at 3-months

    Number of subjects who have 50% or greater pain reduction from baseline

    3 months

Study Arms (1)

Nalu SCS System

OTHER

All eligible subjects will receive the Nalu Neurostimulation System

Device: Nalu Neurostimulation System

Interventions

Nalu Neurostimulation SystemDEVICE

The Nalu Neurostimulation System is a Spinal Cord Stimulation system

Nalu SCS System

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CA Ortho and Spine

Larkspur, California, 94939, United States

Location

IPM Medical Group, Inc.

Walnut Creek, California, 94598, United States

Location

International Spine, Pain and Performance Center

Washington D.C., District of Columbia, 20006, United States

Location

The Orthopaedic Institute

Gainesville, Florida, 32607, United States

Location

Southwest Florida Pain Center

Port Charlotte, Florida, 33948, United States

Location

Alliance Spine and Pain

Atlanta, Georgia, 30326, United States

Location

Neuroscience Research Center

Overland Park, Kansas, 66210, United States

Location

SSM Health

Oklahoma City, Oklahoma, 73106, United States

Location

MeSH Terms

Conditions

Chronic PainPain, IntractableBack PainFailed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Patrick Martin

    Nalu Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 7, 2020

Study Start

July 16, 2020

Primary Completion

September 13, 2022

Study Completion

September 13, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(8)