Dfine has announced that the first patient has been enrolled in the EU-STAR clinical trial. The multicentre trial is the first prospective study to evaluate clinical outcomes in patients receiving treatment with the Star tumour ablation system for the palliative treatment of metastatic spinal tumours.
Dfine will enrol 40 patients at five centres in Germany and France. The trial will evaluate pain relief at one month as a primary outcome measure with follow up through six months. Secondary outcome measures include change in function, quality of life and pain medications post-procedure.
“We’ve had very promising results with targeted radiofrequency ablation (t-RFA) to ‘melt’ the tumour followed by radiofrequency targeted vertebral augmentation (RF-TVA) during the same procedure to repair the damaged vertebrae,” says Boris Joellenbeck, a principal investigator at The Otto-von-Guericke University Magdeburg in Germany, where the first patient was treated. “Immediately following the procedure, the patient had a significant reduction in pain and increased activity level. We are excited about the many potential benefits of this therapeutic approach for our patients.”