Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatment spinal cord stimulator
Sponsor Nevro Corp
Start date June 2012
End date May 2015
Trial size 356 participants
Trial identifier NCT01609972, CA2011 US

Summary

The purpose of this investigational study is to establish the safety and effectiveness of electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the trunk and/or limbs and will be a comparison of the Senza System with commercially available SCS systems.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects randomized to this arm will be trialed and implanted with the Nevro Senza System
spinal cord stimulator
Non-inferior comparison of implantable spinal cord stimulators
(Active Comparator)
Subjects randomized to this arm will be trialed and implanted with a commercially available SCS system.
spinal cord stimulator
Non-inferior comparison of implantable spinal cord stimulators

Primary Outcomes

Measure
Change in back pain VAS and neurological status from Baseline
time frame: 3 months

Secondary Outcomes

Measure
Change in disability as measured by Oswestry Disability Index
time frame: 3, 6, 12 months
Number of subjects with adverse events
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5) which has been refractory to conservative therapy for a minimum of 3 months. - Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician - Be 18 years of age or older at the time of enrollment - Be willing and capable of giving informed consent - Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: - 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, as determined by the Investigator - Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist - Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus - Have a diagnosis of scoliosis that precludes lead placement - Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker - Have prior experience with SCS - Have a condition currently requiring or likely to require the use of MRI or diathermy - Have metastatic malignant disease or active local malignant disease - Have a life expectancy of less than 1 year - Have an active systemic or local infection - Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) - Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) - Be concomitantly participating in another clinical study - Be involved in an injury claim under current litigation - Have a pending or approved worker's compensation claim

Additional Information

Official title Multi-Center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate Non-Inferiority of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Pain as Compared to Commercially Available SCS Devices
Principal investigator Leonardo Kapural, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Nevro Corp.