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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nevro Corp
ClinicalTrials.gov Identifier:
NCT01609972
First received: May 30, 2012
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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 Intervention
Chronic Back Pain
Device: Spinal Cord Stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nevro Corp:

Primary Outcome Measures:
  • Change in back pain VAS and neurological status from Baseline

Secondary Outcome Measures:
  • Change in disability as measured by Oswestry Disability Index
  • Number of subjects with adverse events

Estimated Enrollment: 356
Study Start Date: June 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609972

Sponsors and Collaborators
Nevro Corp
Investigators
Principal Investigator: Leonardo Kapural, MD The Center for Clinical Research, Winston-Salem, NC
  More Information

No publications provided

Responsible Party: Nevro Corp
ClinicalTrials.gov Identifier: NCT01609972     History of Changes
Other Study ID Numbers: CA2011 US
Study First Received: May 30, 2012
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Nevro Corp:
Back pain
Spinal Cord Stimulation

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014