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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | InSightec Industry-sponsored |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Status | Recruiting |
| Started | February 16, 2016 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT05386615 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
- Study coordinator: Nadir Alikacem
- Email: nadira@insightec.com
- Phone: +12146302000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Relugolix (Ryeqo) with low‑dose add-back hormones for uterine fibroids and endometriosis and its effects on blood clotting
This trial will test whether the GnRH antagonist Relugolix combined with low‑dose estradiol and progestin (Ryeqo) changes blood clotting markers in adult women treated for uterine fibroids or endometriosis.
-
Evaluating uterine fibroids using ultrasound techniques before and after treatment
This study is testing if a special ultrasound can help women with uterine fibroids see how their condition changes before and after a specific treatment called uterine artery embolization.
-
Using Bearing nsPVA particles for treating uterine fibroids
This study is testing if a new type of particles used in a procedure can safely help women with painful uterine fibroids feel better.
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Impact of Uterine Fibroids on Women's Fertility
This study looks at how uterine fibroids might affect pregnancy rates in women aged 20-50 who are struggling with infertility.
-
Uterine Fibroids in China: How Common They Are and What Increases Risk
This study tests how common uterine fibroids are in Chinese women and what factors relate to developing them and needing surgery.
-
Vitamin D3 for symptomatic uterine fibroids in women with vitamin D deficiency
This trial will try giving vitamin D3 for six months to women with symptomatic uterine fibroids and low vitamin D to see if their symptoms and fibroid size improve.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.