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OsteoCool Tumor Ablation Post-Market Study (OPuS One)
This study evaluates the effectiveness of the Medtronic OsteoCool¿ RF Ablation System.
5.1.1. Primary Objective(s): To demonstrate an improvement from baseline to 3 months post radiofrequency ablation in worst pain score in the past 24 hours in subjects treated for metastatic lesions in only the thoracic and/or lumbar vertebral body(ies). Worst pain score at the target treatment site will be collected from the Brief Pain Inventory (BPI). 5.1.2. Secondary Objective(s): To characterize change from baseline to 3 months post radiofrequency ablation in worst pain score in the past 24 hours in subjects treated for metastatic lesions in the periacetabulum, iliac crest, and/or sacrum, and for benign bone tumors. Worst pain score at the target treatment site will be collected from the BPI. 5.1.3. Additional Measures: To characterize change in the following measures from baseline to 3 days, 1 week, 1-, 3-, 6-, and 12- months post RF Ablation: Worst pain score at the target treatment site in the past 24 hours (excluding 3-Month visit, listed as primary and secondary endpoints) collected by the BPI. Severity of pain and impact on functioning as measured by the BPI. Health related outcomes as measured by the EuroQol-5D-5L (EQ-5D-5L). Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C15-PAL) (not applicable for subjects with benign bone tumors). Oral morphine equivalent dose (OMED). Overall response rate (subjects treated for metastatic lesions in the vertebral body only). To characterize the patient care continuum (pre and post treatment). To characterize the possible predictors of patient outcomes. To characterize change in worst pain score from baseline to post-RF ablation (prior to discharge). To characterize local tumor control of the treated site pre and post treatment images (e.g., MRI, PET, etc.) US and CAN only.