Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain

Chronic Low Back Pain Clinical Trial

— SENZA-RCT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01609972
• Other study ID #: CA2011 US
• Status: Active, not recruiting
• Phase: N/A
• First received: May 30, 2012
• Last updated: June 30, 2015
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Nevro Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 356
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Device:
• Spinal Cord Stimulator
Non-inferior comparison of implantable spinal cord stimulators

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nevro Corp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in back pain VAS and neurological status from Baseline	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	No
Secondary	Change in disability as measured by Oswestry Disability Index		3, 6, 12 months	No
Secondary	Number of subjects with adverse events		12 months	No