RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
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Details and patient eligibility
About
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
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To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice
Full 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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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
Trial design
4,800 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Thanh Hoang, MS; Stephanie Delvaux
Data sourced from clinicaltrials.gov
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