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Ablatherm® HIFU Clinical Trial
In the context of the FDA approval for Ablatherm® HIFU device, a clinical trial is ongoing and actively recruiting patients in United States.
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 are being recruited into the study. Candidates for study participation must 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.
For more information, and to find out which centres are included in this trial, please visit the ENLIGHT web site http://www.pcaresearch.com/ or call the toll free number 1 800 300 72 52.
