Clinical Trials

The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids. The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate. The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids. The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes changes which are intended to improve device performance and safety. Up and down movement of the ultrasound transducer has been added, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid. Ultrasound energy can also now be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.

The purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. It is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. The investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids.

This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.

The primary objective of this study is to assess the difference in total fluid usage between the Fluent fluid management system and the Aquilex fluid control system.

The primary goal of this study is to compare the safety and effectiveness of two standard fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who do not plan to become pregnant.

A second goal of this study is to better understand which symptoms bother women with fibroids the most. Understanding and addressing the symptoms of clinically-significant uterine fibroids is important in order to optimize treatment outcomes and control health care costs.

Women who are eligible to participate in the study, are randomized to one of two treatment arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to choose which treatment she will receive.

A comprehensive assessment of symptoms-including experienced pain- will take place at baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.

This study is being done to support a device labeling change that will allow women who have uterine fibroids and still wish to become pregnant greater access to the ExAblate treatment. In order for the Sponsor to receive permission to change the labeling, data regarding known pregnancies and their outcome are being gathered to show the known safety hazards to women who might wish to get pregnant after an ExAblate treatment

The purpose of this study is to gain additional information regarding use of Magnetic Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the investigators will use a new noninvasive technology, MRE, to further characterize the elastic properties of the uterine fibroids. To date, very little is known concerning how the tissue composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided Focused Ultrasound (MRgFUS).

In this study, the investigators will use a new noninvasive technology, magnetic resonance elastography (MRE), to further characterize the elastic properties of the uterine fibroids. This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic Resonance Imaging(MRI) can be more difficult to treat.

This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids.

The purpose of this study is to investigate sociocultural influences on menstrual and uterine fibroid (UF) experiences of black women (BW) and hispanics/latinas (HL) with uterine fibroids (UF). Examining these sociocultural influences will demonstrate their impact on UF health disparities and menstrual health discussions to improve health outcomes in these two underserved and understudied populations in biomedical and women’s health research.

Uterine fibroids (UF) are a significant public health concern with a lifetime prevalence of over 70% in all women; however, Black women (BW) have been historically understudied and are disproportionately affected by UF and Hispanic/Latinas (HL) have almost been completely unstudied.

The purpose of this study is:

• To assess how women who have undergone treatment for UF view the experience, whether they prioritize experimental approaches to remedy any impacts on their fertility, and the psychosocial and socio-economic factors most important to them in considering the preservation or restoration of fertility.
• To assess the potential perceptions or experiences of women of African descent compared with women of other ethnic backgrounds of disparities in the symptoms and how treatment options for UF may impact willingness or ability to pursue approaches to fertility maintenance and restoration.

This study will investigate the biology of uterine smooth muscle cells and particularly explore the commonalities it has with smooth muscle cells of the airway.