Clinical trial · Interventional
Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors
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)
NCT02081053CI-TRIAL-00025562EU-STARterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty Enrolling
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Lesions in Vertebral Bodies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- RF Ablation and Vertebral Augmentation
- interventionNames
- Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System
Primary outcomes (1)
- measure
- Pain relief
- timeFrame
- 1 month
- description
- Measured by the Numerical Rating Pain Scale (NRPS)
Secondary outcomes (3)
- measure
- Change in function
- timeFrame
- up to 6 months
- description
- Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.