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This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Spectra™ SCS system programming features | Device | Precision Spectra™ SCS system programming features using the CoverEdge surgical lead. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire | Change in paresthesia distribution based on programming parameters | minimum 25 days post IPG implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roshini Jain | Boston Scientific Neuromodulation Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barolat Neuroscience | Denver | Colorado | 80218 | United States | ||
| Albany Medical Center |
15 subjects were enrolled in the study. 1 subject was enrolled in error who did not meet all inclusion criteria and was withdrawn and 1 subject was lost to follow-up prior to completing the Programming Visit. Statistically relevant conclusions cannot be made from this small sample size.
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| ID | Title | Description |
|---|---|---|
| FG000 | Precision Spectra™ SCS System Programming Features | Precision Spectra™ SCS system programming features using the CoverEdge surgical lead. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Precision Spectra™ SCS System Programming Features | Precision Spectra™ SCS system programming features using the CoverEdge surgical lead. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire | Change in paresthesia distribution based on programming parameters | Posted | Count of Participants | Participants | minimum 25 days post IPG implant |
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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 | Precision Spectra™ SCS System Programming Features | Precision Spectra™ SCS system programming features using the CoverEdge surgical lead. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clincial Sciences | Boston Scientific | 855-213-9890 | BSNClinicalTrials@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2015 | Jul 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Albany |
| New York |
| 12208 |
| United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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