Status:
TERMINATED
Efficacy of the Spinal Cord Stimulation System as Salvage Therapy
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Pain
Intractable Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the efficacy of spinal cord stimulation using the Precision implantable neurostimulation device for chronic and intractable pain of the trunk and or ...
Detailed Description
Chronic pain is managed by the sequential application of various strategies: medications, anesthetic injections, ablation, surgery, implantable intraspinal infusion pumps, and spinal cord stimulation....
Eligibility Criteria
Inclusion
- Have chronic and intractable neuropathic pain of the trunk and/or limbs of moderate to severe intensity and have failed treatment with an intraspinal infusion pump or other SCS device. Determination of failure of treatment will be based on subject feedback. Subjects with an active intraspinal infusion pump but with inadequate pain control will be allowed to participate;
- Be 18 years of age or older;
- Be an appropriate candidate for the surgical procedures required for this study;
- 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 failed immediate past treatment with an intraspinal infusion pump or other SCS device because of technical reasons associated with the device such as unresolved lead migration, battery depletion, etc.;
- Have any evidence of neurologic instability requiring surgery;
- Have any significant medical condition that in the opinion of the investigator may interfere with the conduct of the study or may adversely affect the subject's safety during the study;
- Have any other active implantable device with the exception of a intraspinal infusion pump for pain medications;
- Are pregnant or lactating or planning to become pregnant in the next year;
- Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other investigational drug or device trial while on this study.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00387244
Start Date
August 1 2006
End Date
April 1 2008
Last Update
December 17 2020
Active Locations (1)
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1
Spectrum Care
Napa, California, United States, 94558