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Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Sponsor: Merit Medical Systems, Inc.
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.
Official title: Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-08-22
Completion Date
2026-12
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Bearing nsPVA
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 (4)
Astra Vascular/Astra Vein Treatment Center
Brooklyn, New York, United States
The Wesley Hospital
Brisbane, Australia
Alfred Health
Sydney, Australia
Royal Gwent Hospital (Aneurin Bevan UHB)
Newport, United Kingdom