Uterine Fibroid
Conditions
Keywords
Uterine Fibroids, Exablate
Brief 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.
Detailed 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.
Interventions
DEVICEBody System - Functional
MR-Guided Focused Ultrasound
Sponsors
InSightec
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events | Through study completion, an average of 2 years. | All adverse events and/or serious adverse events will be documented and reported according to protocol. |
Countries
China, United States
Contacts
Primary ContactNadir Alikacem
Outcome results
None listed