US-based Dfine has announced the enrollment of the first patient in the EU-STAR clinical trial, designed to evaluate clinical outcomes in patients receiving treatment with the STAR tumor ablation system for the palliative treatment of metastatic spinal tumors.
The prospective EU-STAR clinical trial will enroll 40 patients at five centers in Germany and France. The multi-center study will assess pain relief at one month as a primary outcome measure with follow up through six months.
Secondary outcome measures of the study include change in function, quality of life and pain medications post-procedure.
Dr Boris Joellenbeck, a principal investigator at The Otto-von-Guericke University Magdeburg in Germany said that they had very promising results with targeted RF ablation (t-RFA) to melt the tumor followed by RF targeted vertebral augmentation (RF-TVA) during the same procedure to repair the damaged vertebrae.
"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," Dr Joellenbeck added.
Dfine CEO Greg Barrett said, "t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of spinal tumors."