Summary

Eligibility
for females ages 18-50 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Steve Raman, MD (ucla)

Description

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.

Details

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.

Keywords

Uterine Fibroid, Uterine Fibroids, Exablate, Leiomyoma, Myofibroma, Body System - Functional

Eligibility

You can join if…

Open to females ages 18-50

    • Eligibility is as per the symptomatic fibroids device indication.
  • All registry-consented patients following the treatment of their fibroid(s) with the Exablate system.

You CAN'T join if...

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Lead Scientist at University of California Health

  • Steve Raman, MD (ucla)
    HS Clinical Professor, Radiological Sciences, Medicine. Authored (or co-authored) 247 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
InSightec
ID
NCT05386615
Study Type
Observational [Patient Registry]
Participants
Expecting 200 study participants
Last Updated