ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain (BM019-Registry)
|Pain Resulting From Bone Metastases||Device: ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)|
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||4 Months|
|Official Title:||A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain|
- Adverse Events [ Time Frame: Two Years ]This study is designed to collect safety data during the first two years of commercial use of ExAblate MRgFUS treatment for palliation of pain resulting from bone metastases.
|Study Start Date:||June 2013|
|Study Completion Date:||April 2017|
|Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Device: ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)
This proposed Registry will be performed in full compliance with all HIPAA rules and their implementations at potential participating sites. All patients planned to undergo the ExAblate procedure in a commercial setting after PMA approval will be offered a consent so they can be included in the ESS. Non-consenting patients will not be included in the ESS. However, information regarding the total number of subjects treated at each participating site with the device will also be collected.
InSightec will set up a (password protected) EDC database for the sites to enter the information of participating subjects treated with the ExAblate device from all U.S. sites using the ExAblate procedure for the bone metastases indication. This will occur for a total duration of 2 years following device approval. It should be noted that any adverse event that meets the Medical Device Report ("MDR") definition will be reported as an MDR as well.
There will be no control group. Reporting to FDA will occur at six-month intervals for the first two-years after PMA approval.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834937
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|University of California San Francisco|
|San Francisco, California, United States, 94107|
|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, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|