At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 50 enrolled
Drug / intervention
ExAblate Enhanced Sonicationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
In Brief
A Phase 3 clinical trial evaluating ExAblate Enhanced Sonication for Uterine Leiomyoma and Uterine Fibroids. Completed, enrolled 50 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Leiomyoma, Uterine Fibroids
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartOct 2006
Primary CompletionAug 2008
TodayJul 2026
First PostedAug 18, 2006
Enrollment StartOct 1, 2006
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.9 years ago
Interventions
ExAblate Enhanced Sonicationdevice