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

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.

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Key information

Conditions

Uterine Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Huashan Hospital Affiliated to Fudan University, Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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: -

Treatment and study plan

Body System - Functional

Device

MR-Guided Focused Ultrasound

Primary outcomes

Occurrence of adverse events

Time frame: Through study completion, an average of 2 years.

All adverse events and/or serious adverse events will be documented and reported according to protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadir Alikacem

CONTACT

[email protected]

+12146302000

Sponsors and collaborators

Lead sponsor

InSightec

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: May 23, 2022
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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