Although available and cleared to markets in European counties, Canada, Australia, and others, the Ablatherm HIFU is not yet approve for market introduction in the United States (US). In order to obtain this approval, the manufacturer must comply with all US Food and Drug Administration (FDA) requirements including the completion of a clinical study.

A phase III clinical study, sponsored by EDAP TMS Inc. has been initiated in the United States. Patient 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. Potential study participants must meet all of the inclusion criteria and none of the exclusion criteria.

The main study inclusion criteria are(1):
• 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 main exclusion criteria are(1):
• 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

If you have been diagnosed with low risk, localized prostate cancer,if you meet the inclusion criteria and none of the exclusion criteria above, and if you are interested in participating in this study, you can find more information about this clinical study :
• via a direct link to the website click HERE or type this address: http://www.clinicaltrials.gov/ct/show/NCT00295802?order=252
(1) A complete list of inclusion and exclusion criteria can be found in the website link provided above.

Disclaimer : Ablatherm® HIFU is not yet approved in the USA

Click here to learn more about the Ablatherm Clinical Trial in the United States