A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

SUMMARY

This study is to comply with the FDA request to conduct a post approval study to assess the safety and effectiveness of the ExAblate device now that it is approved for commercial use by the FDA in the treatment of pain caused by metastatic bone tumors (bone tumors that originally came from another organ) or multiple myeloma.  ExAblate is used commercially for the treatment of bone metastases (it is FDA approved for this use in patients who have received radiation therapy).

Safety will be determined by evaluation of the occurrence and seriousness of device related complications from the first treatment day visit through the 3 months immediately after your treatment.

Effectiveness will be determined using the following assessments:

-Study subject score on the Numerical Rating Scale (a questionnaire designed to measure and describe pain. 

-Comparison of the dose and frequency of pain relief medicine (analgesics/opiate) use from the first (baseline) visit through the 3 month post-treatment follow-up visit.

-Assessment of quality of life as determined by study subject completion of the Brief Pain Inventory – Interference questions (BPI).  This questionnaire asks you general questions about your ability to be involved in social activities and function.

ExAblate treatment works by focusing ultrasound (high frequency sound waves) to heat a small spot much like a magnifying glass can be used to focus light on a spot.  This is called sonication.  Unlike light, ultrasound passes through the skin into the body to a spot your doctor wants to destroy, such as a spot in a tumor.

COH Protocol Number : 13237

ClinicalTrials.gov Number : NCT01833806

Principal Investigator : Wong, Jeffrey M.D.

Sponsor : InSightec, Inc.

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=18

Gender : Either

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :