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

Study Overview
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Brief Summary
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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.

Detailed Description
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Spinal cord stimulation (SCS) is an established therapy for the treatment of chronic pain of the trunk and/or limbs. Standard practice includes a screening trial, typically lasting from 3 days to 7 days or more, for both the physician and the patient to evaluate whether SCS therapy is appropriate for permanent implantation. Screening trial success (hereafter referred to as a trial) is often considered predictive of long-term success of the therapy, although that has never been definitively demonstrated. 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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Non Boston Scientific SCS Trial Therapy
* Device: BSC approved SCS Trial Therapy w/ OMG


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Chronic intractable pain of the trunk and/or lower extremities 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 Key Exclusion Criteria: Primary source of pain is cancer-related, pelvic, visceral or angina 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BSC approved SCS Trial Therapy w/ OMG<br>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) | Device: BSC approved SCS Trial Therapy w/ OMG<br>* 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<br>|
| Active Comparator: Non Boston Scientific SCS Trial Therapy<br>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 | Device: Non Boston Scientific SCS Trial Therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Treatment Preference | Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline | 30 minutes after activation of stimulation |