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

Uterine Fibroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386615
• Other study ID #: UF036
• Status: Recruiting
• Start date: February 16, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: InSightec
• Contact: Nadir Alikacem
• Phone: +12146302000
• Email: nadira[@]insightec.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Intervention

Device:
• Body System - Functional
MR-Guided Focused Ultrasound

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai
China	Shanghai No.1 Hospital	Shanghai
United States	UCLA	Los Angeles	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events	All adverse events and/or serious adverse events will be documented and reported according to protocol.	Through study completion, an average of 2 years.