NL-OMON40764
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Chronische pijn waarvoor geen alternatieve behandeling meer is
- Sponsor
- St. Jude Medical
- Enrollment
- 55
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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