Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Body System - Functional.
- Who it may be relevant to
- Registry conditions: Uterine Fibroid. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Body System - Functional
MR-Guided Focused Ultrasound
Primary outcome measures
- Occurrence of adverse events [Time frame: Through study completion, an average of 2 years.]
Eligibility criteria
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: -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 3 centers
- UCLA — Los Angeles
- Stanford University — Stanford
- Mayo Clinic — Rochester
China · 3 centers
- Huashan Hospital Affiliated to Fudan University — Shanghai
- Shanghai No. 1 Hospital — Shanghai
- Shanghai No.1 Hospital — Shanghai
Identifiers
NCT: NCT05386615 · UF036