A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
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|ClinicalTrials.gov Identifier: NCT01833806|
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : January 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastasis||Device: ExAblate MRgFUS||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||January 14, 2022|
|Actual Study Completion Date :||January 14, 2022|
Experimental: ExAblate Test Arm
Focused Ultrasound Surgery delivered by ExAblate MRgFUS
Device: ExAblate MRgFUS
Focused Ultrasound Ablation
Other Name: Magnetic Resonance guided Focused Ultrasound Surgery
- Proportion of Responders [ Time Frame: Three months ]The statistical hypothesis is that the proportion of responders will be significantly greater than the proportion of subjects experiencing pain progression (worsened pain or increased pain medications usage) by at least 30% or an odds ratio of at least 2.
- Safety Profile [ Time Frame: Three Months ]A full safety profile will be developed for the ExAblate treatment of bone metastases. All adverse events will be captured and summarized as defined in Section-6.2. Adverse events (type, frequency, severity) are expected to be similar to those captured for the original PMA study (PMA # P110039). For his study, the Safety comparison will be descriptive with no statistical endpoints.
- Pain Interference [ Time Frame: Three Months ]Patient overall quality of life status will be assessed by the BPI-QoL Pain Interference scale which will be administered pre-treatment and post-treatment. The trajectory of change may be analyzed descriptively by regression slopes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833806
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|University of California Los Angeles|
|Los Angeles, California, United States, 90024|
|University of California San Francisco|
|San Francisco, California, United States, 94107|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Weill Cornell Medical Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|