NCT00365989

MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: InSightec · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Uterine Leiomyoma
• Uterine Fibroids

Interventions

Type	Name	Description
DEVICE	ExAblate Enhanced Sonication

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-08-18
• Last updated: 2019-02-05
• Results posted: 2019-02-05

Locations

5 sites across 2 countries: United States, Canada