RELIEF A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Primary Objective
To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practices, when used according to the applicable Directions for Use.
Secondary Objective
To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practices
Design
The study is a prospective, multi-center, global registry of BSC neurostimulation systems for pain. The study will enroll up to 4800 subjects who are scheduled to undergo trial therapy with a commercially made available BSC neurostimulation device at up to 150 global centers. It is expected that 4800 enrolled subjects will yield at least 3000 permanently implanted subjects. Negative trials, subjects who do not have a successful neurostimulation trial outcome, will complete participation after completion of the End of Neurostimulation Trial Period visit. Subjects who have not proceeded to IPG implantation with a BSC IPG by the 12 Months Post Neurostimulation Trial visit will complete participation after completion of the 12 Months Post Neurostimulation Trial visit, and all other subjects will be followed for 36 months.

Study phase: IV

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

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 (DFU)
Signed a valid, IRB/EC-approved informed consent form
18 years of age or older when written informed consent is obtained
Exclusion Criteria
Meets any contraindication in BSC neurostimulation system local DFU
Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate’s ability to assess pain relief or complete study assessments

Primary disease category: Pain Control

Sponsor: Boston Scientific Neuromodulation Corporation

Protocol number: A7007

Projected enrollment dates: April 2015 to December 2018

Official study title: RELIEF A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain