Clinical trial Recruiting at 5 sites Observational Ages 18 to 50 Women only

Registry for pregnancy outcomes after Exablate treatment for uterine fibroids

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

Run by InSightec · NCT05386615 · Data updated 2026-11-12

This study is looking to see how the Exablate treatment for uterine fibroids affects pregnancy outcomes in people who have had the procedure.

More Uterine Fibroid trials

Quick facts

Study typeObservational
Ages18 Years to 50 Years
SexWomen only
Enrollment200 (estimated)
SponsorInSightec
Industry-sponsored
Locations6 sites (Los Angeles, California and 5 other locations)
StatusRecruiting
StartedFebruary 16, 2016
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 30, 2025
Trial IDNCT05386615 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women who have been treated for symptomatic uterine fibroids using the Exablate system and have consented to participate in the registry.

Probably not a fit

Patients who have not undergone Exablate treatment or those with asymptomatic fibroids may not receive any benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry study aims to collect data on clinical pregnancy outcomes and treatment backgrounds for individuals who have undergone Exablate treatment for symptomatic uterine fibroids. Participants will be monitored for two years post-treatment to assess the impact of the Exablate procedure on pregnancy occurrences. The study is designed to gather safety data and inform potential updates to labeling regarding the treatment's effects on fertility.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of Exablate treatment regarding pregnancy outcomes for women with uterine fibroids.

How similar studies have gone: While this study is observational and focuses on pregnancy outcomes post-treatment, similar studies have shown promise in understanding the effects of fibroid treatments on fertility.

Who can join: the full rules

Show full inclusion / exclusion criteria
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: -

Where it's running

  • UCLA
    Los Angeles, California, United States
    Recruiting
  • Stanford University
    Stanford, California, United States
    Recruiting
  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting
  • Shanghai No. 1 Hospital
    Shanghai, China
    Recruiting
  • Shanghai No.1 Hospital
    Shanghai, China
    Recruiting
  • Huashan Hospital Affiliated to Fudan University
    Shanghai, China
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.