RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Conditions

Pain

Keywords

stimulation, implantable, pulse generator, back pain, chronic pain, leg pain

Brief 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

Detailed 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.

Reinen JM, Agurto C, Cecchi G, NAVITAS and ENVISION Studies Physician Author Group, Boston Scientific Research Scientists Consortium, Rogers JL.

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10.1038/s41746-025-02084-1

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Pain Management2023-01-2425 citations

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ESRA19-0159 A prospective global registry of real-world outcomes using spinal cord stimulation systems for chronic pain

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2019-08-301 citations

10.1136/rapm-2019-esraabs2019.67

Interventions

DEVICEneurostimulation system

Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion 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

Countries

Argentina, Australia, Belgium, Canada, Colombia, Denmark, Germany, Israel, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

CONTACTThanh Hoang, MS

BSNClinicalTrials@bsci.com855-213-9890

CONTACTStephanie Delvaux