Clinical trial NCT01834937: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Official title: A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain Resulting From Bone Metastases
Keywords: ExAblate
MRgFUS
Bone Metastases
Pain Palliation
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2013-04-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consented patients from all participating US sites who receive the commercial ExAblate procedure during the first year after approval will be included. This study/registry will examine treatment background information such adverse events, primary cancer type, treatment frequency, etc., reported in patients undergoing the device procedure for the first two years of commercial experience.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: Two Years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: