Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Boston Scientific Corporation
Study ID
NCT01643213
Status
Completed

Conditions

  • Chronic Pain

Eligibility Criteria

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

Interventions

  • Non Boston Scientific SCS Trial Therapy — DEVICE
    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 — DEVICE
    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

Study Details

The purpose of this study is to evaluate patient preference of the Boston Scientific Corporation (BSC) commercially approved spinal cord stimulation (SCS) systems with the Observational Mechanical Gateway (OMG) in patients who failed non-BSC SCS trial therapy.

Key Dates

First listed
Jul 18, 2012
Start date
Jul 31, 2012
Status verified
Nov 2020
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 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)
  • Active Comparator: 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

Primary Outcome Measure

Subject's Treatment Preference [ Time Frame: 30 minutes after activation of stimulation ]

Locations (13)

FacilityCityStateZIPSite coordinators
Hope Research InstitutePhoenixArizona85018-
NeurovationsNapaCalifornia94558-
Comprehensive Pain SpecialistsBroomfieldColorado80020-
Coastal Orthopedics and Sports Medicine of Southwest Florida, PABradentonFlorida34209-
Southeastern Integrated MedicalGainesvilleFlorida32607-
Compass Research, LLCOrlandoFlorida32806-
Rush University Medical CenterChicagoIllinois60612-
Global Scientific Innovations - Advanced Pain Care ClinicEvansvilleIndiana47714-
Columbia Interventional Pain CenterColumbiaMissouri65201-
Southern New York NeuroSurgical GroupJohnson CityNew York13790-
New York Spine and Wellness CenterNorth SyracuseNew York13212-
Riverhills Healthcare IncorporatedCincinnatiOhio45242-
West Virginia University HospitalsMorgantownWest Virginia26506-

Find similar trials in Phoenix, AZ

By research site
Hope Research Institute· Phoenix, AZNeurovations· Napa, CAComprehensive Pain Specialists· Broomfield, COCoastal Orthopedics and Sports Medicine of Southwest Florida, PA· Bradenton, FLSoutheastern Integrated Medical· Gainesville, FLCompass Research, LLC· Orlando, FL

Related Studies