NCT01142791

Safety Study of ExAblate for the Treatment of Uterine Fibroids

A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: InSightec · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins. The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids. The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DEVICE	ExAblate	Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-06-11
• Last updated: 2019-03-19
• Results posted: 2019-03-06

Locations

8 sites across 1 country: United States