Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
InSightec
Summary
The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.
Description
This is an observational study only for all consented subjects who undergo an Exablate treatment. The Exablate procedure is a commercial treatment. The objective of this registry is to collect data about the effect of Exablate treatment on potential pregnancy occurrences in this population for two years post-treatment for purposes of labeling updates and overall safety data collection.
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: - - Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system. Exclusion Criteria: -
Interventions
- DeviceBody System - Functional
MR-Guided Focused Ultrasound
Locations (6)
- UCLALos Angeles, California
- Stanford UniversityStanford, California
- Mayo ClinicRochester, Minnesota
- Huashan Hospital Affiliated to Fudan UniversityShanghai
- Shanghai No. 1 HospitalShanghai
- Shanghai No.1 HospitalShanghai