Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 27
- Locations
- 13
- Primary Endpoint
- Subject's Treatment Preference
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
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)
Intervention: BSC approved SCS Trial Therapy w/ OMG (Device)
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
Intervention: Non Boston Scientific SCS Trial Therapy (Device)
Outcomes
Primary Outcomes
Subject's Treatment Preference
Time Frame: 30 minutes after activation of stimulation
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
Secondary Outcomes
No secondary outcomes reported