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Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain (SENZA-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01609972
Recruitment Status : Unknown
Verified June 2015 by Nevro Corp.
Recruitment status was:  Active, not recruiting
First Posted : June 1, 2012
Last Update Posted : July 2, 2015
Information provided by (Responsible Party):
Nevro Corp

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Spinal Cord Stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2012
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test
Subjects randomized to this arm will be trialed and implanted with the Nevro Senza System
Device: Spinal Cord Stimulator
Non-inferior comparison of implantable spinal cord stimulators

Active Comparator: Control
Subjects randomized to this arm will be trialed and implanted with a commercially available SCS system.
Device: Spinal Cord Stimulator
Non-inferior comparison of implantable spinal cord stimulators

Primary Outcome Measures :
  1. Change in back pain VAS and neurological status from Baseline [ Time Frame: 3 months ]
    The primary endpoint is a composite of effectiveness and safety. Specifically, the primary endpoint is the percentage of randomized subjects (the ITT analysis population) and subjects completing the Primary Efficacy Assessment (the PP analysis population) who respond to SCS therapy (as assessed by VAS) for back pain and do not have a stimulation-related neurological deficit at the Primary Efficacy Assessment (non-inferiority analysis). Subjects who do not have a successful Trial Phase are considered failures (non-responders) toward the primary endpoint.

Secondary Outcome Measures :
  1. Change in disability as measured by Oswestry Disability Index [ Time Frame: 3, 6, 12 months ]
  2. Number of subjects with adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609972

Sponsors and Collaborators
Nevro Corp
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Principal Investigator: Leonardo Kapural, MD The Center for Clinical Research, Winston-Salem, NC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nevro Corp
ClinicalTrials.gov Identifier: NCT01609972    
Other Study ID Numbers: CA2011 US
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: June 2015
Keywords provided by Nevro Corp:
Back pain
Spinal Cord Stimulation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Neurologic Manifestations