NCT06153667

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroid

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-08-22
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-12-01
• Last updated: 2026-04-01

Locations

4 sites across 3 countries: United States, Australia, United Kingdom