Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Uterine Fibroids are the most common benign tumors in pre- and peri-menopausal women.
Fibroids occur in 20-50% of women over 30 years of age, and with increasing size can produce
pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids
may also cause infertility. Symptomatic fibroids impact health and well-being of the female
including lost work hours and reduced quality of life.
Current medical treatments include invasive removal of the fibroid (hysterectomy,
myomectomy), drug therapy, or treatments causing necrosis of the fibroid tissue such as
ablation (freezing or heating) or embolization. It has been estimated that 600,000
hysterectomies are performed per year in the United States and more than half of the
conducted hysterectomies are due to fibroids. For the relief of symptoms, women wishing to
preserve the uterus may choose between invasive procedures of myomectomy, Uterine Artery
Embolization (UAE), ablation or cryotherapy. The surgically invasive procedures require
anesthesia, hospital stays, and long recovery periods. However, High Intensity Focused
Ultrasound (HIFU) shows promising results in relieving fibroid symptoms.
This study will confirm the safety and clinical effectiveness of Philips Sonalleve MR-HIFU
Fibroid Therapy system for ablating symptomatic fibroids.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Alternative Interventional Treatment (AIT)
AIT is scored dichotomously as follows: 0 = Failure. Failure occurs if an AIT for fibroid related symptoms is administered within 12 months of study treatment. 1 = Success. Success occurs if no AIT is administered for fibroid related symptoms within 12 months of study treatment. An AIT is defined as being one of the following: hysterectomy, myomectomy, uterine artery embolization, endometrial ablation and resection, or another MR-HIFU treatment (with the exception of a 're-treatment' as defined in the protocol, e.g. because of temporarily inaccessible fibroids).
12 months after HIFU treatment
John H Fischer II, MD
St. Luke's Episcopal Hospital, Houston, Texas, United States
United States: Food and Drug Administration
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|University of Chicago||Chicago, Illinois 60637|
|St. Luke's Episcopal Hospital||Houston, Texas 77030|
|Vanderbilt Medical Center||Nashville, Tennessee 37232-2765|