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

DFINE

Status

Terminated

Conditions

Metastatic Lesions in Vertebral Bodies

Treatments

Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02081053

DF-13-03

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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