NCT02081053TerminatedNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- DFINE Inc.
- Enrollment
- 30
- Locations
- 13
- Primary Endpoint
- Pain relief
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Pain relief
Time Frame: 1 month
Measured by the Numerical Rating Pain Scale (NRPS)
Secondary Outcomes
- Change in pain medications(up to 6 months)
- Change in function(up to 6 months)
- Change in Quality of Life(up to 6 months)
Investigators
Study Sites (13)
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