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To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation | Experimental | Spectra WaveWriter SCS System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectra WaveWriter SCS System | Device | Multiple modalities of stimulation therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline | 3 months post activation |
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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 |
|---|---|---|---|---|---|---|
| Neurovations | Napa | California | 94558 | United States | ||
| Louis J. Raso, MD, PA |
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Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and proceed in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation | Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 10, 2019 |
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| Jupiter |
| Florida |
| 33477 |
| United States |
| Florida Pain Clinic | Ocala | Florida | 34471 | United States |
| Forest Health Medical Center | Ypsilanti | Michigan | 48198 | United States |
| Mercy Medical Research Institute | Springfield | Missouri | 65804 | United States |
| University of Rochester | Rochester | New York | 14618 | United States |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Western Reserve Spine and Pain Institute | Kent | Ohio | 44240 | United States |
| Toledo Clinic | Toledo | Ohio | 43623 | United States |
| West Chester Hospital, LLC | West Chester | Ohio | 45069 | United States |
| Pacific Sports and Spine, LLC | Eugene | Oregon | 97401 | United States |
| Spine Team Texas | Rockwall | Texas | 75032 | United States |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | United States |
| Advanced Pain Management Appleton | Appleton | Wisconsin | 54913 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Stimulation | Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline | Posted | Count of Participants | Participants | 3 months post activation |
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Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
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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 | Spinal Cord Stimulation | Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy | 1 | 97 | 7 | 97 | 0 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus Node Dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Sciences | Boston Scientific | 661 949 4350 | roshini.jain@bsci.com |
| Feb 27, 2020 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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