Spots Global Cancer Trial Database for Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
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Trial Identification
Brief Title: Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
Official Title: Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Study ID: NCT01504308
Conditions
Study Description
Brief Summary: 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).
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Chicago, Chicago, Illinois, United States
University of Michigan, Ann Arbor, Michigan, United States
Montefiore Medical Center, Bronx, New York, United States
Oregon Science and Health University, Portland, Oregon, United States
Vanderbilt Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
St. Luke's Episcopal Hospital, Houston, Texas, United States
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Samsung Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: John H Fischer II, MD
Affiliation: St. Luke's Episcopal Hospital, Houston, Texas, United States
Role: PRINCIPAL_INVESTIGATOR
Name: Robert K Zurawin, MD
Affiliation: St. Luke's Episcopal Hospital, Houston, Texas, United States
Role: PRINCIPAL_INVESTIGATOR
Name: Elizabeth David, MD
Affiliation: Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
Role: PRINCIPAL_INVESTIGATOR
Name: Hyo Keun Lim, MD
Affiliation: Samsung Medical Center, Seoul, Republic of Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Aytekin Oto, MD
Affiliation: University of Chicago, Chicago, Illinois, United States
Role: PRINCIPAL_INVESTIGATOR
Name: Amanda Yunker, D.O.
Affiliation: Vanderbilt Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Liu, M.D.
Affiliation: University of Michigan
Role: PRINCIPAL_INVESTIGATOR
Name: Rajiv Chopra, PhD
Affiliation: University of Texas Southwestern Medical Center
Role: PRINCIPAL_INVESTIGATOR
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