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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01834937
First received: April 12, 2013
Last updated: April 24, 2014
Last verified: April 2014
  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 Phase
Pain Resulting From Bone Metastases
Device: ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)
Phase 4

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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834937

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Maria Brookes    626-256-4673 ext 64402    mbrooks@coh.org   
Principal Investigator: Jeff Wong, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Fizaa Ahmed    650-725-6409    Fizaa@stanford.edu   
Principal Investigator: Pejman Ghanouni, MD, PhD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie Sathre    507-538-0540    sathre@mayo.edu   
Principal Investigator: David Woodrum, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Parchayi Dalal       PD9D@hscmail.mcc.virginia.edu   
Principal Investigator: James Larner, MD         
Sponsors and Collaborators
InSightec
  More Information

No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01834937     History of Changes
Other Study ID Numbers: BM019-Registry, BM019-Registry
Study First Received: April 12, 2013
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
ExAblate
MRgFUS
Bone Metastases
Pain Palliation

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasm Metastasis
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplastic Processes
Pathologic Processes
Hematologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014