OsteoCool Tumour Ablation Post-Market Study

Official Title

OsteoCool Tumour Ablation Post-Market Study (OPuS One)

Summary:

This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.

Trial Description

Primary Outcome:

  • Improvement of worst pain score
Secondary Outcome:
  • Change in worst pain score
The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States, Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of this study is to collect real-world outcomes among a cohort of patients in the US, EUR and CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy), and in EUR and CAN, benign bone tumours such as osteoid osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study will collect device, procedure and/or therapy related adverse events and device deficiencies. Lastly, subject outcomes (such as pain relief, quality of life, and function) will be evaluated using validated assessment measures.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society