Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors

Study Overview
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Brief Summary
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To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.

Official Title
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A Prospective, Multicenter Clinical Study to Evaluate the Clinical Outcomes of Targeted Radiofrequency Ablation and Vertebral Augmentation to Treat Painful Metastatic Vertebral Body Tumor(s)

Conditions
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Metastatic Lesions in Vertebral Bodies

Intervention / Treatment
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* Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One to 2 painful vertebrae (T1-L5) with evidence of osteolytic metastatic lesion with known primary histology with pathologic fracture(s) at index vertebra by MRI Pain score ≥ 4 on the numerical rating pain scale Life expectancy of ≥ 6 months Exclusion Criteria: Primary tumors of the bone at index vertebra Benign tumors of the bone at index vertebra Osteoblastic tumors at index vertebra Index vertebra with more than one (1) pedicle involved Epidural extension of tumor within 5 mm of the spinal cord or without sufficient room for thermal protective maneuvers Spinal cord compression or canal compromise requiring decompression Radiation therapy is planned to be started on the index vertebra within 4 weeks post procedure Radiation therapy was performed on the index vertebra within 2 months before enrollment Major surgery of the spine was performed within 3 months before enrollment Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RF Ablation and Vertebral Augmentation<br> | Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System<br>* Radiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Measured by the Numerical Rating Pain Scale (NRPS) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in function | Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI) | up to 6 months | 
| Change in Quality of Life | Measured by European Organization for Research and Treatment of Cancer and Bone Metastasis Questionnaires (EORTC-C30 and EORTC-BM22) | up to 6 months | 
| Change in pain medications |  | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic lesions, vertebral body, ablation, targeted radio-frequency ablation, radio-frequency targeted vertebral augmentation, radiofrequency kyphoplasty, spine, vertebral augmentation, kyphoplasty, spinal ablation, pain, quality of life