Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Merit Medical Systems, Inc.
100 participants
Aug 22, 2024
OBSERVATIONAL
Conditions
Summary
This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.
Eligibility
Inclusion Criteria3
- 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 Criteria3
- 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).
Interventions
Bearing nsPVA Embolization Particles are irregularly-shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters. Bearing nsPVA Embolization Particles are used for the embolization of symptomatic (leiomyoma uteri) uterine fibroids.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06153667