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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01834937
First Posted: April 18, 2013
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
InSightec
  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.

Condition Intervention
Pain Resulting From Bone Metastases Device: ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Two Years ]
    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.


Enrollment: 17
Study Start Date: June 2013
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834937


Locations
United States, California
City of Hope
Duarte, California, United States, 91010
University of California San Francisco
San Francisco, California, United States, 94107
Stanford University
Stanford, California, United States, 94305
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
InSightec
  More Information

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01834937     History of Changes
Other Study ID Numbers: BM019-Registry
BM019-Registry ( Registry Identifier: BM019-Registry )
First Submitted: April 12, 2013
First Posted: April 18, 2013
Last Update Posted: May 18, 2017
Last Verified: May 2017

Keywords provided by InSightec:
ExAblate
MRgFUS
Bone Metastases
Pain Palliation

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes