Status:
COMPLETED
Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial
Lead Sponsor:
Abbott Medical Devices
Conditions:
Chronic, Intractable Pain of the Trunk and/or Lower Limbs
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, multi-center, randomized, single blind study
Detailed Description
This clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for BurstDR™ during the trial evaluation period with the St Jude Medical™ Invi...
Eligibility Criteria
Inclusion
- Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
- Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
- Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation.
- Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use.
- Patient is \>18 years of age at the time of enrollment.
- Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
- Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.
Exclusion
- Patient currently has a spinal cord stimulation system implanted.
- Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
- Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
- Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
- Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2018
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT03277378
Start Date
September 22 2017
End Date
October 12 2018
Last Update
January 5 2021
Active Locations (25)
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1
Jason Edward Pope, MD
Santa Rosa, California, United States, 95403
2
Comprehensive Spine Institute
Clearwater, Florida, United States, 33765
3
Florida Pain Institute
Merritt Island, Florida, United States, 32953
4
National Pain Institute Winter Park
Winter Park, Florida, United States, 32789