A Pivotal Study to Evaluate the Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases
Men and women aged 18 and older.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at enrollment.
Patients who are able and willing to give consent and able to attend all study visits.
Patients who are suffering from painful bone metastases.
need surgical stabilization of the affected bony structure (>7 fracture risk score), Or
targeted tumor is at an impending fracture site (>7 on fracture risk score), Or
patients with surgical stabilization of tumor site with metallic hardware. (2) Targeted (treated) lesion is in the skull. (3) Patients on dialysis. (4) Patients with life expectancy < 3-Months. (5) Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
Unstable angina pectoris on medication,
EpiSonica
Lead sponsor