NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation Systems
NCT ID: NCT03240588
Last Updated: 2025-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
544 participants
INTERVENTIONAL
2017-07-31
2024-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study
Patients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus.
Neurostimulation System
Spinal cord stimulation
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study
Patients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
Neurostimulation System
Spinal cord stimulation
Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study
Patients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated.
All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
Neurostimulation System
Spinal cord stimulation
Interventions
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Neurostimulation System
Spinal cord stimulation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Natalie Bloom Lyons, M.S.
Role: STUDY_DIRECTOR
Boston Scientific Neuromodulation Corporation
Locations
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Hope Research Institute
Phoenix, Arizona, United States
Banner University Medical Center
Tucson, Arizona, United States
Coastal Research Institute
Carlsbad, California, United States
South Lake Pain Institute, Inc
Clermont, Florida, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, United States
Forest Health Medical Center
Ypsilanti, Michigan, United States
KC Pain Centers
Lee's Summit, Missouri, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, United States
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States
Precision Spine Care
Tyler, Texas, United States
Washington Center for Pain Management
Bellevue, Washington, United States
EvergreenHealth Pain Care
Kirkland, 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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92366204
Identifier Type: OTHER
Identifier Source: secondary_id
92100126
Identifier Type: -
Identifier Source: org_study_id
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