Using Bearing nsPVA particles for treating uterine fibroids
Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
This study is testing if a new type of particles used in a procedure can safely help women with painful uterine fibroids feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Merit Medical Systems, Inc. Industry-sponsored |
| Locations | 4 sites (Brooklyn, New York and 3 other locations) |
| Trial ID | NCT06153667 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the safety and performance outcomes of Bearing nsPVA Embolization Particles used in uterine artery embolization for symptomatic uterine fibroids. It involves adult women who meet specific eligibility criteria and will follow participants for six months post-treatment. The study is multicenter and focuses on real-world outcomes following the use of this embolization technique.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 and older with symptomatic uterine fibroids that are suitable for embolization.
Not a fit: Patients who are pregnant, have pelvic infections, or malignancies in the pelvic region may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness and safety of Bearing nsPVA particles for treating uterine fibroids, potentially improving patient care.
How similar studies have performed: While this approach is observational and may not have been extensively tested in this specific context, similar embolization techniques have shown promise in treating uterine fibroids.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult women ≥ 18 years old at the time of enrollment. * Subject has symptomatic uterine fibroid(s), suitable to embolization. * Subject provides written informed consent. Exclusion Criteria: * Subject is pregnant. * Subject has suspected pelvic inflammatory disease or any other pelvic infection. * Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).
Where this trial is running
Brooklyn, New York and 3 other locations
- Astra Vascular/Astra Vein Treatment Center — Brooklyn, New York, United States (Recruiting)
- The Wesley Hospital — Brisbane, Australia (Recruiting)
- Alfred Health — Sydney, Australia (Recruiting)
- Royal Gwent Hospital (Aneurin Bevan UHB) — Newport, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Molly Ryan
- Email: molly.ryan@merit.com
- Phone: 314-620-7095
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.