Registry for pregnancy outcomes after Exablate treatment for uterine fibroids
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | InSightec Industry-sponsored |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT05386615 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have not undergone Exablate treatment or those with asymptomatic fibroids may not receive any benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California and 5 other locations
- UCLA — Los Angeles, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Huashan Hospital Affiliated to Fudan University — Shanghai, China (Active_not_recruiting)
- Shanghai No. 1 Hospital — Shanghai, China (Recruiting)
- Shanghai No.1 Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Nadir Alikacem
- Email: nadira@insightec.com
- Phone: +12146302000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.