06.12.14
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.
Boris Joellenbeck, M.D., 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.
“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,” said CEO Greg Barrett.
Dfine Inc. is a spine device company based in San Jose, Calif.
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.
Boris Joellenbeck, M.D., 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.
“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,” said CEO Greg Barrett.
Dfine Inc. is a spine device company based in San Jose, Calif.