A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes
This trial is active, not recruiting.
|Treatments||conventional single source programming, precision spectra scs system advanced programming|
|Sponsor||Boston Scientific Corporation|
|Start date||February 2015|
|End date||September 2016|
|Trial size||90 participants|
|Trial identifier||NCT02384096, 90968587|
The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
Change in percent paresthesia coverage of targeted pain while minimizing unwanted paresthesia
time frame: 7, 14 days post activation
Male or female participants at least 18 years old.
Inclusion Criteria: - Meets RELIEF Registry criteria for inclusion - Primary complaint of persistent or recurrent low back pain, with or without leg pain - Signed a valid, IRB/EC-approved informed consent form Exclusion Criteria: - Meets any RELIEF Registry criteria for exclusion
|Official title||COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes|
|Description||The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain. The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.|
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