Randomized, ControlleD, Single Blinded, ProspEctive, MuLtIcenter Study EValuating Anatomic versus Targeted lead placement for Burst DR Therapy during the Trial Evaluation period - Delivery

St. Jude Medical0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•1. Patient is indicated for SCS therapy in accordance with the approved labeling.
•2. Patient*s pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
•3. Patient has a baseline score on the NRS *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.
•4. 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.
•5. Patient is >18 years of age at the time of enrollment.
•6. Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
•7. Patient has signed and received a copy of the EC/IRB approved informed consent.

•1. Patient currently has a spinal cord stimulation system implanted.
•2. Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
•3. Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
•4. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure).
•5. Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).
•6. Patient is currently participating in another clinical investigation with an active treatment arm.
•7. Patient is unable to read and/or write.

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