Study of Bearing nsPVA Embolization Particles to Treat Symptomatic Uterine Fibroids Using Uterine Artery Embolization

What this Trial Is About

Researchers are conducting a prospective, multicenter observational study to follow up on individuals treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. The study focuses on collecting data regarding the safety and performance of these particles over a six-month period. The study is sponsored by Merit Medical Systems, Inc. and involves adult women with symptomatic uterine fibroids suitable for embolization. The intervention being observed is the use of Bearing nsPVA Embolization Particles, which are irregularly-shaped, biocompatible particles made from polyvinyl alcohol. These particles are designed to block or reduce blood flow in targeted blood vessels through selective catheter placement. The study tracks outcomes following the use of this device in treating uterine fibroids, with no comparison groups or placebo treatments. Participants will be monitored for safety outcomes up to 30 days and effectiveness outcomes through six months after treatment. Data collection will include evaluations related to the devices performance and participant health status during follow-up visits. The overall participation duration includes the initial treatment and subsequent monitoring over half a year to assess treatment impact and safety.

Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)