OsteoCool Tumor Ablation Post-Market Study

Inclusion Criteria

• Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region
• A. Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors - no restrictions on location of lesion
• Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
• Localized pain resulting from no more than two sites total of metastatic disease
• Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone tumors)
• Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
• At least 18 years old at the time of informed consent

Exclusion Criteria

• A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only)
• Use of OsteoCool in vertebral body levels C1-C7
• Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone
• Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection
• Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise
• Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression
• Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or mixed origin are eligible for the study
• Pregnant, breastfeeding, or plan to become pregnant during the study duration
• Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*
• Any condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation
• Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic's study manager to determine if the subject can be enrolled in both studies.