- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02703818
SCS for the Treatment Of Chronic Pain of the Upper Extremities (UEP)
November 29, 2018 updated by: Nevro Corp
Multi-Center, Prospective, Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment Of Chronic Pain of the Upper Extremities
This is a prospective, multi-center post-market study of the Senza System in subjects with chronic, intractable pain of the upper extremities.
Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.
Study Overview
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Redwood City, California, United States, 94065
- NEVRO Corp
-
-
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
Key Inclusion Criteria:
- Have been diagnosed with chronic, intractable pain of an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
- Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
- Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
- Be 18 years of age or older at the time of enrollment.
- Be an appropriate candidate for the surgical procedures required in this study.
- Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
- Have stable neurological status measured by motor, sensory and reflex function.
Key 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.
- Have a current diagnosis of a progressive neurological disease.
- Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
- Have mechanical spine instability as determined.
- Have significant stenosis, based on MRI.
- Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
- Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
- 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, alcohol or illicit drugs.
- Be involved in an injury claim under current litigation.
- Have a pending or approved worker's compensation claim.
- 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Senza
Spinal Cord Stimulation for UEP
|
Spinal Cord Stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Responder Rate
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David Caraway, MD, NEVRO Corp
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.
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 (Actual)
February 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
March 2, 2016
First Submitted That Met QC Criteria
March 3, 2016
First Posted (Estimate)
March 9, 2016
Study Record Updates
Last Update Posted (Actual)
December 3, 2018
Last Update Submitted That Met QC Criteria
November 29, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA2015-4 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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