About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Subjects who exhibit an on-label indication for neurostimulation to relieve chronic intractable pain, according to the Instructions for Use, as applicable in each country or region
Trial design
Cohort
Prospective
Treatments tested in this trial
neurostimulation system
DeviceTrial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Treatment groups
Trial outcomes
Other outcomes
Percent Pain Relief
Percent pain relief of targeted pain at 6, 12, 24, 36, 48, and 60 months follow up
Percent Pain Relief
Percent pain relief of low back pain at 6, 12, 24, 36, 48, and 60 months follow up
Percent Pain Relief
Percent pain relief of leg pain at 6, 12, 24, 36, 48, and 60 months follow up
Change in QoL
Change in quality of life as reported by the Subject at
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