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Clinical Trial Summary

This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.


Clinical Trial Description

Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00365989
Study type Interventional
Source InSightec
Contact
Status Completed
Phase Phase 3
Start date October 2006
Completion date August 2008

See also
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