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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain Resulting From Bone Metastases
• Intervention / Treatment: Device: ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)

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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • San Francisco, California, United States, 94107
      • University of California San Francisco
    • Stanford, California, United States, 94305
      • Stanford University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: InSightec

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 12, 2013
• First Submitted That Met QC Criteria: April 16, 2013
• First Posted (Estimate): April 18, 2013

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: MRgFUS; ExAblate; Bone Metastases; Pain Palliation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: BM019-Registry (Registry Identifier: BM019-Registry)