Uterine Fibroids Clinical Trial
Official title:
Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (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.
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