Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors

Inclusion Criteria: * Patients with painful metastatic malignant lesions involving bone; * Patients, candidates to standard therapy, in which the RF ablation can be performed in combination with the Standard Therapy in accordance with the Investigator's indications; * Patients who have failed, not candidates or refuse Standard Therapy (chemotherapy or radiotherapy); * Patients with metastatic tumor size compatible with the expected ablation dimensions as reported for SPINERY devices in the IFU; * Patients with localized pain resulting from not more than two sites of symptomatic metastatic disease * Patients that do not have evidence of impending fracture * Patients with metastatic lesions targeted for treatment located in the thoracic and/or lumbar vertebral body(ies), peri-acetabulum, iliac crest, and/or sacrum - no restrictions on location of lesion; * Patients with BPI-Report worst pain score ≥4/10 at the target treatment site within the past 24 hours * Patients with Karnofsky score ≥ 40 at enrollment * Patients willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls * Patients at least 18 years old at the time of informed consent Exclusion Criteria: * Patients implanted with heart pacemaker or other implanted electronic device * Patients with previous mechanical bone stabilization in the vertebral body to be treated * Use of SPINERY in vertebral body levels C1-C7 * Multiple myeloma, solitary plasmacy…