Ablatherm® HIFU Clinical Trial
In the context of the FDA approval for Ablatherm® HIFU device, a clinical trial is ongoing in United States - currently in the patient follow-up phase (patient recruitement is closed).
Phase III Ablatherm® HIFU FDA clinical trial
A phase III clinical study for Ablatherm® HIFU, sponsored by EDAP TMS Inc. has been initiated in the United States. Patients diagnosed with low risk localized prostate cancer were recruited into the study. The recruitment phase of the study is complete and patients are now being followed. Candidates for study participation had to meet study inclusion/exclusion criteria prior to study enrollment.
HIFU has received regulatory clearance and is marketed in Europe, Canada, Australia and others outside of the US. Ablatherm® HIFU is seeking approval for market introduction in the US following FDA requirements including completion of this Phase III Clinical Trial.