NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation Systems

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Boston Scientific Corporation
Study ID
NCT03240588
Status
Completed

Conditions

  • Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neurostimulation System — DEVICE
    Spinal cord stimulation

Study Details

The objective of the study is to characterize the relationship between select objective metrics and clinical outcomes in chronic pain patients treated with Boston Scientific commercially approved neurostimulation systems.

Key Dates

First listed
Aug 7, 2017
Start date
Jul 31, 2017
Status verified
May 2025
Primary completion
Mar 8, 2024
Completion
Mar 8, 2024

Study Design

Enrollment
544 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Pain Responder Rate [ Time Frame: 12 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
Hope Research InstitutePhoenixArizona85018-
Banner University Medical CenterTucsonArizona85724-
Coastal Research InstituteCarlsbadCalifornia92009-
South Lake Pain Institute, IncClermontFlorida34711-
University of Florida Shands HospitalGainesvilleFlorida32608-
Tallahassee Neurological Clinic, PATallahasseeFlorida32308-
Ochsner Clinic FoundationNew OrleansLouisiana70115-
Willis-Knighton River Cities Clinical Research CenterShreveportLouisiana71105-
Forest Health Medical CenterYpsilantiMichigan48198-
KC Pain CentersLee's SummitMissouri64086-
The Center for Clinical Research, LLCWinston-SalemNorth Carolina27103-
Pacific Sports and Spine, LLCEugeneOregon97401-
PCPMG Clinical Research Unit, LLCGreenvilleSouth Carolina29601-
Precision Spine CareTylerTexas75701-
Washington Center for Pain ManagementBellevueWashington98004-
EvergreenHealth Pain CareKirklandWashington98034-

Find similar trials in Phoenix, AZ

By research site
Hope Research Institute· Phoenix, AZBanner University Medical Center· Tucson, AZCoastal Research Institute· Carlsbad, CASouth Lake Pain Institute, Inc· Clermont, FLUniversity of Florida Shands Hospital· Gainesville, FLTallahassee Neurological Clinic, PA· Tallahassee, FL

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