Status:
COMPLETED
An Implantable Spinal Cord Stimulation Pain Management System
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chronic Pain
Pain, Intractable
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Ther...
Detailed Description
This clinical trial was a confirmatory study for the Advanced Bionics totally implantable Spnial Cord Stimulation(SCS) System, the Stimulus System. This system is indicated as an aid in the management...
Eligibility Criteria
Inclusion
- Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain.
- Be an appropriate candidate for surgery.
- Be capable of giving informed consent.
- Be capable and willing to follow all study related procedures.
Exclusion
- Have an inability to operate the system either by self or care-giver.
- Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study.
- Have any implanted electrical devices, regardless of whether active or inactive.
- Have any active implantable device regardless of whether stimulation is ON or OFF.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00205855
Start Date
February 1 2003
End Date
March 1 2005
Last Update
October 26 2012
Active Locations (9)
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1
Alabama Pain Center
Huntsville, Alabama, United States, 35801
2
California Pain Medicine Centers
Los Angeles, California, United States, 90059
3
Pacific Pain Treatment Center
San Francisco, California, United States, 94109
4
Yellowstone Neurological Associates
Billings, Montana, United States, 59101