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  • Worldwide Retrospective Pregnancy Data Collection: ExAblate Treatment of Symptomatic Uterine Fibroids Rochester, Minn.

    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

Closed for Enrollment

  • A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids Rochester, Minn.

    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.
  • Use of Ultrasound-based Methods to Visualize and Characterize the Age and Natural History of Venous Thrombosis in Patients Undergoing Great Saphenous Vein Ablation Rochester, Minn.

    The purpose of this study is to evaluate strain imaging, 3-D volume ultrasonography and elastic properties of thrombus to determine if these properties can be used to evaluate the age of thrombus. 
     
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