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ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Not Recruiting
Trial ID: NCT01834937
Purpose
The purpose of this enhanced surveillance study ("ESS") is to collect information regarding
chronic adverse events that are possibly related to the ExAblate® System ("ExAblate") that
are received by InSightec ("InSightec") following PMA approval. This study will examine
adverse events reported in patients undergoing the device procedure for the first two years
of commercial experience. Other relevant data may be collected as well.
Official Title
A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Stanford Investigator(s)
Pejman Ghanouni, MD, PhD
Associate Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology
Eligibility
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.
Intervention(s):
device: ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061