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

April 19, 2023 updated by: InSightec
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Active, not recruiting
        • HuaShan Hospital Affiliated To Fudan University
      • Shanghai, China
        • Recruiting
        • Shanghai No.1 Hospital
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

pre- and peri- menopausal women with Uterine Fibroids

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exablate
Observational study of Exablate treatment.
Device: Body System - Functional
MR-Guided Focused Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2016

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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