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Ethanol

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.

Bearing nsPVA

Irene Coughlin

Casey Holland

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.

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

The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.

The primary effectiveness endpoint will be clinical success defined as ≥ 50% improvement in the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Symptom Severity subscale at 6 months as compared to baseline.

Merit Medical Systems, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)	NCT06153667	Uterine Fibroid	Bearing nsPVA	18 Years -	Merit Medical Systems, Inc.
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)	NCT06153667	Uterine Fibroid	Bearing nsPVA	18 Years -	Merit Medical Systems, Inc.
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)	NCT06153667	Uterine Fibroid	Bearing nsPVA	18 Years -	Merit Medical Systems, Inc.

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