Status:
TERMINATED
Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Back Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode i...
Detailed Description
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed in parallel at T8-T9 vertebral levels. A common problem after surgery is the migration of leads fro...
Eligibility Criteria
Inclusion
- Have FBSS with moderate to severe back or lower extremity pain of at least 3 months duration, be an appropriate candidate for SCS, and have independently elected SCS therapy with the Precision system as next line therapy;
- Be 18 years of age or older;
- Be willing and able to comply with all study related procedures and visits;
- Be capable of reading and understanding patient information materials and giving written informed consent.
Exclusion
- Have low back pain as the primary complaint;
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints;
- Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00386724
Start Date
October 1 2006
End Date
August 1 2008
Last Update
December 17 2020
Active Locations (2)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
2
Neurosurgical Specialist
Norfolk, Virginia, United States, 23510