Last updated on September 2017

A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain


Brief description of study

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.

Detailed Study Description

As part of the PMA # P110039 review process and approval, InSightec was requested to conduct a post-approval study. Patients will be treated following the approved commercial treatment guidelines. For this study, participating sites will use the ExAblate device for the administration of the ExAblate treatment. This study will be performed on either 1.5T or 3T MR scanners. For this study, a total of 70 patients meeting the approved commercial guidelines will be enrolled and treated with the ExAblate system at from 7 to 10 sites. The proportion of responders is expected to be at least 30% greater than the proportion of subjects experiencing pain progression (i.e., 60% vs. 30%). Additionally, at the 3 month visit, an analysis of both the safety and efficacy profiles will be compared to the original PMA pivotal study group.

Clinical Study Identifier: NCT01833806

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Jeff Wong, MD

City of Hope
Duarte, CA United States
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David Lu, MD

University of California Los Angeles
Los Angeles, CA United States
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Thomas Link, M.D.

University of California San Francisco
San Francisco, CA United States
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Stanford University School of Medicine
Stanford, CA United States
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David Woodrum, MD

Mayo Clinic
Rochester, MN United States
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Bradley B. Pua, MD

Weill Cornell Medical Center
New York, NY United States
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Joshua Meyer, MD

Fox Chase Cancer Center
Philadelphia, PA United States
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MD Anderson
Houston, TX United States
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University of Virginia
Charlottesville, VA United States
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