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RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
- and -
To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice
The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.
A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
- RELIEF
- A7007
- 90876777 (Andere Kennung) (BSC protocol number)
implantable
pulse generator
back pain
chronic pain
leg pain
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Boston Scientific SCS Systems Subjects permanently implanted with a Boston Scientific neurostimulation systems | Neurostimulation System Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome |
- Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
- Signed a valid, IRB/EC-approved informed consent form
- 18 years of age or older
- Contraindicated for Boston Scientific neurostimulation system
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
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