Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids

NCT05386615 · tracked via the Priya Life Science China tracker

Sponsor

InSightec

Phase

Observational

Started

2016-02-16

Last updated

2025-04-30

Condition(s) studied

Uterine Fibroid

Investigational drug(s) / intervention(s)

Body System - Functional

Body System - Functional: MR-Guided Focused Ultrasound

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

50 Years

Healthy volunteers

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: -

Primary outcome measure(s)

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.

Trial sites (6)

Facility	City	Region	Status
UCLA	Los Angeles	California	Recruiting
Stanford University	Stanford	California	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
Huashan Hospital Affiliated to Fudan University	Shanghai	China	Active Not Recruiting
Shanghai No. 1 Hospital	Shanghai	China	Recruiting
Shanghai No.1 Hospital	Shanghai	China	Recruiting

Other trials for the same condition

Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids Active, not recruiting

Radiomics-Based Non-Invasive MRI Differentiation of Uterine Sarcomas and Fibroids Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05386615 on ClinicalTrials.gov ↗ ← All trials in China