ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain (BM019-Registry)

InSightec

Status: Terminated

Conditions: Pain Resulting From Bone Metastases

Treatments: Device: ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)

Study type: Observational

Funder types: Industry

Identifiers

NCT01834937

BM019-Registry (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.