Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
- Conditions
- Uterine Fibroid
- Registration Number
- NCT05386615
- Lead Sponsor
- InSightec
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
-
- Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Shanghai No. 1 Hospital
🇨🇳Shanghai, China
UCLA
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Stanford, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
Shanghai No.1 Hospital
🇨🇳Shanghai, China
Shanghai No. 1 Hospital🇨🇳Shanghai, ChinaHan Wang, MDContact+86 181 2128 910913564112852@163.com