Metastatic Lesions in Vertebral Bodies
Conditions
Brief summary
Registry collecting data on use of The STAR™ Tumor Ablation System.
Detailed description
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 STAR™ Tumor Ablation System.
Interventions
Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.
Sponsors
Study design
Eligibility
Inclusion criteria
* Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System. * Have signed informed consent
Exclusion criteria
* Subjects under 18 years old * Subjects with heart pacemakers, or other electronic device implants * Subjects intended for t-RFA in vertebral body levels C1-7
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief (Numerical Rating Pain Scale), post t-RFA | 1 month | measured by Numerical Rating Pain Scale (NRPS, 0-10 scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale) | 1 week, 1 month, 3 month, 6 month, 12 month | measured by the FACT G7 & Numerical Rating Pain Scale |
Countries
United States