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Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).
In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Varied Pulse (TVP)-SCS settings | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific WaveWriter Alphaâ„¢ SCS Systems | Device | Time Varied Pulse (TVP)-SCS settings |
|
| Measure | Description | Time Frame |
|---|---|---|
| Targeted Pain Responder Rate | Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation | 3 months post-activation |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thanh Hoang | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com | |
| Diane Keesey | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Natalie M Bloom Lyons | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Back Pain Specialists | Recruiting | Greenwood | Colorado | 80111 | United States |
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| Orlando Health Neuroscience Institute | Recruiting | Clermont | Florida | 24711 | United States |
|
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70115 | United States |
|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
|
| Fox Chase Pain Management | Recruiting | Trevose | Pennsylvania | 19053 | United States |
|
| PCPMG Clinical Research Unit, LLC | Recruiting | Greenville | South Carolina | 29601 | United States |
|
| Institute of Precision Pain Medicine | Recruiting | Corpus Christi | Texas | 78414 | United States |
|
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010148 | Pain, Intractable |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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