Clinical Trials (Now Enrolling!)

Ablatherm® HIFU is not yet approved in the USA.

• United States

US clinical trial enrollment & contact information

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.

The inclusion criteria are:

• Male subject 60 years or older.
• Organ-confined prostate cancer (localized prostate cancer).
• No previous treatment for prostate cancer.
• PSA = 10 mg/ml and cancer stage not greater than T2a.

The exclusion criteria are:

• Any previous treatment for prostate cancer
• Previous surgery or procedure of the prostate (except prostate biopsy) or urethra within the prior one year
• Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease

Complete information about this clinical trial visit