SONATA Treatment for Uterine Fibroids

STUDY BASICS

Do you have uterine fibroids and experience heavy bleeding during your period? If so, you may be able to take part in a research study evaluating an investigational new outpatient treatment that may provide an alternative to hysterectomy. Compensation provided.

STUDY PURPOSE

Millions of women with uterine fibroids struggle with heavy bleeding during their periods. The purpose of this research study is to find out if a new, investigational device (The SONATA System) can provide a safe and effective way to reduce the heavy bleeding associated with fibroids. The study device accesses fibroids through the cervix, requiring no abdominal incisions and leaving no visible scars. The SONATA system allows a physician to view fibroids with ultrasound imaging (sound waves), to help the physician accurately deliver heat energy to fibroids. Researchers hope that this device will provide an alternative to hysterectomy (surgical removal of the uterus).

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 25-50
• Heavy menstrual bleeding caused by uterine fibroids
• Not pregnant and have no desire to become pregnant in the future

WHAT PARTICIPANTS CAN EXPECT

Study participation requires up to 9 study visits, including one 6-hour treatment visit and two MRIs.