Trials / Recruiting
RecruitingNCT01719055
RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,800 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | neurostimulation system | Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome |
Timeline
- Start date
- 2012-11-19
- Primary completion
- 2035-05-01
- Completion
- 2035-05-01
- First posted
- 2012-11-01
- Last updated
- 2026-04-13
Locations
118 sites across 16 countries: United States, Argentina, Australia, Belgium, Canada, Colombia, Denmark, Germany, Israel, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01719055. Inclusion in this directory is not an endorsement.