At a glance
ClinicalIndex Comparison RecordN/ACompleted· 9 enrolled
Drug / intervention
ExAblate 2000device
Likely dose
ExAblate 2000 device (MR-guided focused ultrasound)AI-extracted
Key inclusion· 5
- ✓Symptomatic uterine fibroids, not seeking treatment to improve fertility
- ✓Pre- or peri-menopausal status (within 12 months of last menstrual period)
- ✓Device-accessible fibroids (positioned without being shielded by bowel or bone)
- ✓Fibroids clearly visible on non-contrast MRI
Key exclusion· 10
- ✕Metallic implants incompatible with MRI
- ✕Sensitivity to MRI contrast agents
- ✕Severe claustrophobia preventing MR unit completion
- ✕Current or desired pregnancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
In Brief
A clinical study evaluating ExAblate 2000 for Leiomyoma. Completed, enrolled 9 participants across 1 site.
Detailed Summary
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.'
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeiomyoma
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2005
Enrollment StartJan 2006
Primary CompletionJan 2009
Study CompletionFeb 2009
TodayJul 2026
First PostedAug 18, 2005
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2009
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.9 years ago
Interventions
ExAblate 2000device