ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

Pain Resulting From Bone Metastases Clinical Trial

— BM019-Registry  

Official title:

A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01834937
• Other study ID #: BM019-Registry
• Secondary ID: BM019-Registry
• Status: Terminated
• Start date: June 2013
• Est. completion date: April 2017

Study information

• Verified date: November 2018
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Pain Resulting From Bone Metastases

Intervention

Device:
• ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)
Focused Ultrasound Surgery - FUS delivered by ExAblate for the palliation of pain due to bone metastases.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	City of Hope	Duarte	California
United States	Weill Cornell Medical Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California San Francisco	San Francisco	California
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	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.	Two Years