RecruitingObservational

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

NCT ID: NCT05386615Sponsor: InSightecLast updated: 2025-04-30

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.

Arms & interventions

DeviceBody System - Functional
MR-Guided Focused Ultrasound

Outcome measures

Primary

Occurrence of adverse events
All adverse events and/or serious adverse events will be documented and reported according to protocol.
Time frame: Through study completion, an average of 2 years.

Eligibility criteria

Sex: FemaleAge: 18 Years to 50 YearsHealthy volunteers: No

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 locations (3)

UCLA

Los Angeles, California, 90095

Recruiting

Polly Kay, RN, CCRP · Contact

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

Steve Raman, MD · Principal Investigator

Stanford University

Stanford, California, 94305

Recruiting

Caroline Huang · Contact

650-725-6409 chuang99@stanford.edu

Pejman Ghanouni, MD, PhD · Principal Investigator

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting

Brittany Yaklich · Contact

507-538-7765 FOCUSEDULTRASOUND@mayo.edu

Gina Hesley, MD · Principal Investigator