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SLUHN 2017-81

Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Susan A. Hahn
    484-526-7825
    susan.hahn2@sluhn.org

  • Synopsis: You are being asked to be in this study because you and your doctor decided that you will receive the Algovita Spinal Cord Stimulation (SCS) System. The Algovita SCS System is to be used as a part of your health care team’s plan to manage your ongoing pain of the trunk and/or limbs, including one-sided (unilateral) or two-sided (bilateral) pain related to failed back surgery syndrome, intractable (stubborn) low back pain and leg pain. When the stimulation is on, you may feel a tingling or numbing (paresthesia) sensation that overlaps your area of pain.

    The purpose of this study is to evaluate the effectiveness (success) and safety of Algovita SCS system under real-world use. If you agree to be in this study, you will continue to receive your usual care with your study doctor that will include permanent implant of the Algovita SCS system. Information about your treatment progress and experience with the SCS system will be collected as part of this study. The Algovita SCS system is approved for sale in Europe and the United States; the Algovita SCS system is not experimental.

    • Patient is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
    • Patient had successful Algovita SCS system stimulation trial and will be implanted with a permanent Algovita SCS system
    • Patient is willing and able to sign an IRB/EC approved informed consent
    • Patient is contraindicated for an Algovita SCS system
    • Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
    • Patient has a life expectancy of less than 2 years
    • Patient is participating in another clinical study that would confound data analysis
    • Patient has a coexisting pain condition that might confound pain ratings