Recruiting

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

Sponsor:

InSightec

Code:

NCT05386615

Conditions

Uterine Fibroid

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Body System - Functional

Study Details

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.

Conditions

Uterine Fibroid

Study ID

NCT05386615

Start date

Feb 16, 2016

Status verified date

Apr, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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: -

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Exablate

Observational study of Exablate treatment.

Interventions

Body System - Functional

MR-Guided Focused Ultrasound

Primary outcome measure

Occurrence of adverse events [ Time Frame: Through study completion, an average of 2 years. ]

Central Contacts and Locations

Central contacts

Nadir Alikacem

+12146302000 nadira@insightec.com

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Polly Kay, RN, CCRP

310-794-0376 pkay@mednet.ucla.edu

Principal Investigator:

Steve Raman, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Caroline Huang

650-725-6409 chuang99@stanford.edu

Principal Investigator:

Pejman Ghanouni, MD, PhD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Brittany Yaklich

507-538-7765 FOCUSEDULTRASOUND@mayo.edu

Principal Investigator:

Gina Hesley, MD

More Information

Sponsor

InSightec

Last update posted

Apr 30, 2025

Last verified

Apr, 2025

Keywords

Uterine Fibroids
Exablate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by InSightec on 2025-04-30.