Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
CompletedNot applicableNCT01643213
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
- Conditions
- Interventions
- Device: Non Boston Scientific SCS Trial Therapy
- Device: BSC approved SCS Trial Therapy w/ OMG
- Sponsor
- Boston Scientific Corporation
- Start date
- 2012-07
- Primary completion
- 2015-02
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 13
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01643213