A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
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
There will be no control group. Reporting to FDA will occur at six-month intervals for the
first two-years after PMA approval.
Observational [Patient Registry]
Observational Model: Cohort, Time Perspective: Prospective
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.
United States: Food and Drug Administration