Ongoing Ablatherm-HIFU U.S. Clinical Study Protocol Amended
March 11th, 2009 Posted in hifuEDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, has received approval from U.S. Food and Drug Administration (FDA) to introduce amendaments to the protocol for the ENLIGHT trial. This trial is the Company’s ongoing U.S. clinical study of Ablatherm-HIFU (high intensity focused ultrasound) for the treatment of patients with localized prostate cancer
The FDA approved the following protocol amendments:
- Minimum patient age of 50 years old (formerly 60 years of age)
- Potential to add three clinical trial sites to the Ablatherm-HIFU study arm, for a total of 27 participating U.S. sites
- Replacement of the required five day follow-up visit with a telephone call consultation
- Inclusion of patients currently treated with alpha blockers and saw palmetto