A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Boston Scientific Corporation
Summary
To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Instructions for Use \- and - To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice
Description
The study is a prospective, multi-center, global, post-market study of Boston Scientific neurostimulation systems for pain. 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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
Interventions
- Deviceneurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Locations (118)
- Physicians Research Group, LLCPhoenix, Arizona
- Hope Research InstitutePhoenix, Arizona
- Banner University Medical CenterTucson, Arizona
- Comprehensive Pain Management CenterCampbell, California
- Coastal Research InstituteCarlsbad, California
- Pain Medicine Associates, Inc.Fountain Valley, California