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Difficulty Enrolling
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| Name | Class |
|---|---|
| DFINE Inc. | INDUSTRY |
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Registry collecting data on use of The STARâ„¢ Tumor Ablation System.
The STAR Prospective Registry is an observational registry to gather clinical safety and outcome data in patients with painful spinal metastases in the thoracolumbar spine (T1-L5) following targeted radiofrequency ablation (t-RFA) treatment with the STARâ„¢ Tumor Ablation System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Targeted Radiofrequency Ablation (t-RFA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STARâ„¢ Tumor Ablation System | Device | Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief (Numerical Rating Pain Scale), post t-RFA | measured by Numerical Rating Pain Scale (NRPS, 0-10 scale) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale) | measured by the FACT G7 & Numerical Rating Pain Scale | 1 week, 1 month, 3 month, 6 month, 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STARâ„¢ Tumor Ablation System.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Medical Center | Concord | California | 94520 | United States | ||
| Southern California Institute of Neurological Surgery |
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| Escondido |
| California |
| 92025 |
| United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| St. Joseph's Medical Center | Stockton | California | 95204 | United States |
| University of Colorado | Denver | Colorado | 80045 | United States |
| Mori Bean and Brook Radiology | Jacksonville | Florida | 32216 | United States |
| Medical Imaging & Therapeutics | Lady Lake | Florida | 32159 | United States |
| VIR Chicago | Chicago | Illinois | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Tennessee | Knoxville | Tennessee | 37920 | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | United States |