N/A
Completed N=27
Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
Source: ClinicalTrials.gov NCT01643213 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Subject's Treatment Preference — 6; 3; 1; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject's Treatment Preference |
6; 3; 1; 2; 1; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01643213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.