The study, which is expected to enroll 224 women between 18 and 50 years old, represents the next leg of Philips’ journey toward FDA approval of its Sonalleve MR-HIFU system as a treatment for uterine fibroids, benign tumors that affect 20-50 percent of pre-menopausal women over 30 years old.Three sites are now recruiting uterine fibroid patients for a Phase II/III study assessing the safety and efficacy of the Sonalleve MR-guided focused ultrasound system manufactured by Philips Healthcare. The study – Philips Pivotal Clinical Trial for MRI-HIFU of Uterine Fibroids– is now recruiting patients at St. Luke’s Episcopal Hospital in Houston, Texas, USA, Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada and Samsung Medical Center in Seoul, Korea. Patient recruitment is pending at two other U.S. study sites, Johns Hopkins Hospital in Baltimore, Maryland and the University of Chicago in Chicago, Illinois.
During the trial, patients will be randomly assigned to treatment or control groups. Those in the treatment group will receive focused ultrasound therapy; control group participants will undergo a simulated treatment in which no therapeutic ultrasound doses are delivered. Participants will be followed for 12 months.
Written by Ellen C., McKenna