SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study (SPARTA)

This is an interventional treatment trial for Vertebral Metastasis Read More

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 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 of 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.