A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Trial status: Open for Enrollment
Why is this study being done?
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.
Who is eligible to participate?
This study collects safety data on patient treatments performed commercially under the FDA approved labeling.
- Eligibility is as per approved device indication.
- All registry-consented patients who undergo commercial ExAblate procedure for bone mets palliation after device approval.