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  • A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain Rochester, Minn.

    The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.

  • A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain Rochester, Minn.

    The purpose of this enhanced surveillance study ("ESS") is to collect information regarding chronic adverse events that are possibly related to the ExAblate® System ("ExAblate") that are received by InSightec ("InSightec") following PMA approval. This study will examine adverse events reported in patients undergoing the device procedure for the first two years of commercial experience. Other relevant data may be collected as well.

  • Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions Rochester, Minn.

    The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.

  • Magnetic Resonance Elastography (MRE) of Uterine Fibroids (MRE) Rochester, Minn.

    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.

  • MRI-Guided Cryoablation for Focal Native Prostate Cancer Rochester, Minn.

    The purpose of this study is to investigate MR-guided cryoablation of biopsy proven Gleason 7 prostate cancers using the Galil MR-compatible cryoablation system to monitor the technqiue and prospectively collect the data.  The system is already FDA (510k) approved for soft tissue ablation and has been utilized successfully at Mayo previously. 

  • Multi-center Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE) Rochester, Minn.

    The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in patients with pulmonary metastatic disease. This study is to enroll patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5cm. Patients will be followed 24 months post their cryoablation procedure.

  • Prospective Use of Real-time MRI Rochester, Minn.

    This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.

  • Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Hepatic Tumors Rochester, Minn.

    This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

  • Technical Success, Safety, and Short-Term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences Rochester, Minn.

    The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.

  • The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects Rochester, Minn.

    The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).

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