Expired Study
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Valencia, California 91355


Purpose:

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.


Study summary:

The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). 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.


Criteria:

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


NCT ID:

NCT02384096


Primary Contact:

Study Director
Kristen Lechleiter, M.S.
Boston Scientific Neuromodulation Corporation


Backup Contact:

N/A


Location Contact:

Valencia, California 91355
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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