Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
NCT ID: NCT01643213
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
27 participants
INTERVENTIONAL
2012-07-31
2015-02-28
Brief Summary
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Detailed Description
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Boston Scientific Corporation (BSC) developed the Observational Mechanical Gateway (OMG) connectors to allow patients who previously underwent an SCS trial using Medtronic or St Jude Medical leads, operating room cables (OR-cables), and external trial stimulators (ETSs), to be able to connect to BSC commercially approved Spinal Cord Stimulation (SCS) trial systems to evaluate the BSC SCS therapy in the physician office setting prior to removal of the non-BSC leads.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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BSC approved SCS Trial Therapy w/ OMG
Precision Plus SCS Trial Therapy w/ OMG. Spinal cord stimulation (SCS) trial therapy activated using FDA-approved BSC SCS trial systems with the Observational Mechanical Gateway(OMG) to connect to non-BSC lead(s)
BSC approved SCS Trial Therapy w/ OMG
No procedures will be attempted as part of this study. This intervention refers to connection and activation of all Boston Scientific commercially approved SCS trial systems for 30 minutes of SCS therapy for pain
Non Boston Scientific SCS Trial Therapy
Non Boston Scientific SCS Trial Therapy. Spinal cord stimulation (SCS) trial therapy activated using FDA-approved non BSC SCS system that the subject was implanted with, and received SCS therapy from, prior to study enrollment
Non Boston Scientific SCS Trial Therapy
No procedures will be attempted as part of this study. This intervention refers to connection and activation of a previously implanted and programmed FDA-approved non Boston Scientific SCS trial system for 30 minutes of SCS therapy for pain
Interventions
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Non Boston Scientific SCS Trial Therapy
No procedures will be attempted as part of this study. This intervention refers to connection and activation of a previously implanted and programmed FDA-approved non Boston Scientific SCS trial system for 30 minutes of SCS therapy for pain
BSC approved SCS Trial Therapy w/ OMG
No procedures will be attempted as part of this study. This intervention refers to connection and activation of all Boston Scientific commercially approved SCS trial systems for 30 minutes of SCS therapy for pain
Eligibility Criteria
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Inclusion Criteria
* History of trunk and/or lower extremity pain lasting at least 6 months
* Study candidate completed a spinal cord stimulation (SCS) trial of a FDA-approved non-Boston Scientific Corporation (non-BSC) system, exclusively for the treatment of chronic intractable pain of the trunk and/or lower extremities, that will not proceed to permanent implantation due to unsatisfactory treatment or in the physician's opinion received sub-optimal results
* Currently implanted with FDA-approved non-BSC SCS lead(s) exclusively in the thoracolumbar epidural space that are temporarily anchored for non-surgical removal at the termination of the screening trial period and which are approved for use with either the Observational Mechanical Gateway (OMG) A or OMG-M, per the OMG directions for use
Exclusion Criteria
* Investigator-suspected gross lead migration during the non-BSC trial period which may preclude the study candidate from receiving adequate SCS therapy
* Study candidate reports \<10% paresthesia coverage of overall pain while running the preferred stimulation settings on the non-BSC SCS system at the end of the non-BSC SCS screening trial period
* Study candidate unwilling to tolerate implantation with an SCS system
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Roshini Jain
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Hope Research Institute
Phoenix, Arizona, United States
Neurovations
Napa, California, United States
Comprehensive Pain Specialists
Broomfield, Colorado, United States
Coastal Orthopedics and Sports Medicine of Southwest Florida, PA
Bradenton, Florida, United States
Southeastern Integrated Medical
Gainesville, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Global Scientific Innovations - Advanced Pain Care Clinic
Evansville, Indiana, United States
Columbia Interventional Pain Center
Columbia, Missouri, United States
Southern New York NeuroSurgical Group
Johnson City, New York, United States
New York Spine and Wellness Center
North Syracuse, New York, United States
Riverhills Healthcare Incorporated
Cincinnati, Ohio, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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A7006
Identifier Type: OTHER
Identifier Source: secondary_id
A7006
Identifier Type: -
Identifier Source: org_study_id