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| ID | Type | Description | Link |
|---|---|---|---|
| 20130370 | Other Identifier | WIRB |
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Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Lesions to the spine | Patients over the age of 18 receiving treatment using the DFINE Inc. STAR tumor ablation system for palliation of painful metastases of the spine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Mean change from baseline in worst pain score per NRPS at one month | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Change from baseline at each visit using Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP) | 3 months |
| Change if Quality of Life | Change from baseline at each visit using Functional Assessment of Cancer Therapy (FACT-G7) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with painful spinal metastases following t-RFA with the STAR™ Tumor Ablation System.
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| Name | Affiliation | Role |
|---|---|---|
| Sandeep Bagla, MD | Inova Alexandria Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palomar Pomerado Health System | Escondido | California | 92027 | United States | ||
| University of Southern California |
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| 3 months |
| Change in Function | Change from baseline at each visit using Modified Oswestry Disability Index (MODI) | 3 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Suburban Hospital | Bethesda | Maryland | 20814 | United States |
| Austin Radiological Associates | Austin | Texas | 78759 | United States |
| St. Mark's Hospital | Salt Lake City | Utah | 84107 | United States |
| Inova Alexandria Hospital | Alexandria | Virginia | 22304 | United States |
| Providence Sacred Heart Hospital | Spokane | Washington | 99204 | United States |