Ensayos clínicos

Inclusion Criteria:

• Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region.
• 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 (Europe and Canada only) – 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 not more than two sites 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:

• 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.