A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or limbs - Prodigy-I study

St. Jude Medical0 个研究点目标入组 55 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•o Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
•o Patient is considered by the investigator as a candidate for implantation of a SCS system
•o Patient is >= 18 years of age
•o Patient must be willing and able to comply with study requirements
•o Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

•o Patient is immune-compromised
•o Patient has history of cancer requiring active treatment in the last 6 months
•o Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
•o Patients with a SCS system or implantable infusion pump implanted previously
•o Patient has a life expectancy of less than one year
•o Patient is pregnant or is planning to become pregnant during the duration of the investigation
•o Patient is unable to comply with the follow up schedule
•o Patient needing legally authorized representative
•o Patient unable to read and write
•o Patient is currently participating in another clinical investigation with an active treatment arm

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