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

June 30, 2015 updated by: Nevro Corp

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

356

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nevro Corp

Investigators

  • Principal Investigator: Leonardo Kapural, MD, The Center for Clinical Research, Winston-Salem, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA2011 US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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