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| ID | Type | Description | Link |
|---|---|---|---|
| A7006 | Other Identifier | Boston Scientific |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSC approved SCS Trial Therapy w/ OMG | Experimental | 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) |
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| Non Boston Scientific SCS Trial Therapy | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roshini Jain | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85018 | United States | ||
| Neurovations |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment to Control | Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy) |
| FG001 | Control to Treatment | Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
|
| Napa |
| California |
| 94558 |
| United States |
| Comprehensive Pain Specialists | Broomfield | Colorado | 80020 | United States |
| Coastal Orthopedics and Sports Medicine of Southwest Florida, PA | Bradenton | Florida | 34209 | United States |
| Southeastern Integrated Medical | Gainesville | Florida | 32607 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Global Scientific Innovations - Advanced Pain Care Clinic | Evansville | Indiana | 47714 | United States |
| Columbia Interventional Pain Center | Columbia | Missouri | 65201 | United States |
| Southern New York NeuroSurgical Group | Johnson City | New York | 13790 | United States |
| New York Spine and Wellness Center | North Syracuse | New York | 13212 | United States |
| Riverhills Healthcare Incorporated | Cincinnati | Ohio | 45242 | United States |
| West Virginia University Hospitals | Morgantown | West Virginia | 26506 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment to Control | Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy) |
| BG001 | Control to Treatment | Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment: United States | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 30 minutes after activation of stimulation |
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180 days post randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment to Control | Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy) | 0 | 13 | 0 | 13 | ||
| EG001 | Control to Treatment | Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy) | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Information | Boston Scientific | 855-213-9890 | BSNClinicalTrials@bsci.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Period 1 No, Period 2 Yes |
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| Period 1 No, Period 2 No |
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