Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation
NCT ID: NCT02093793
Last Updated: 2020-11-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
383 participants
INTERVENTIONAL
2014-03-27
2019-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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High Rate Spinal Cord Stimulation
PRECISION SCS Adapted for High-Rate SCS
PRECISION SCS Adapted for High-Rate SCS
Comparison of spinal cord stimulation parameters
Commercial Rate Spinal Cord Stimulation
PRECISION SCS Adapted for High-Rate SCS
PRECISION SCS Adapted for High-Rate SCS
Comparison of spinal cord stimulation parameters
Interventions
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PRECISION SCS Adapted for High-Rate SCS
Comparison of spinal cord stimulation parameters
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
* Be 22 years of age or older at the time of enrollment
* Be willing and capable of giving informed consent
* Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion Criteria
* Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
* Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
* Have a current systemic infection, or local infection in close proximity to anticipated surgical field
* Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
* Be participating in another clinical study that may influence the data collected for the study
22 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Wallace, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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Hope Research Institute
Phoenix, Arizona, United States
Coastal Pain & Spinal Diagnostics
Carlsbad, California, United States
UCSD Medical Center - Jacobs Medical Center
La Jolla, California, United States
San Diego Pain Institute
San Diego, California, United States
Compass Research, LLC
Orlando, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, United States
MAPS Applied Research Center
Edina, Minnesota, United States
Mayo Clinic Foundation
Rochester, Minnesota, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
Hope Research Institute
Las Vegas, Nevada, United States
Premier Pain Centers, LLC
Shrewsbury, New Jersey, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, United States
Pain Consultants of Oregon
Eugene, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
Oregon Neurosurgery
Springfield, Oregon, United States
Precision Spine Care
Tyler, Texas, United States
Pacific Medical Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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A4007
Identifier Type: -
Identifier Source: org_study_id